Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- MQENeedle, Assisted Reproduction2Product Code
- MQFCatheter, Assisted Reproduction2Product Code
- MQGAccessory, Assisted Reproduction2Product Code
- MQHMicrotools, Assisted Reproduction (Pipettes)2Product Code
- MQIMicrotool Fabrication, Assisted Reproduction2Product Code
- MQJMicromanipulators And Microinjectors, Assisted Reproduction2Product Code
- MQKLabware, Assisted Reproduction2Product Code
- MQLMedia, Reproductive2Product Code
- K242561Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)2Cleared 510(K)
- K242089Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)2Cleared 510(K)
- K242107CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)2Cleared 510(K)
- K241833V-GRAD2Cleared 510(K)
- K242043Sperm Freezing Medium2Cleared 510(K)
- K241132ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)2Cleared 510(K)
- K241095ARTSMedia Semen Wash Medium2Cleared 510(K)
- K242968Giftlife® Single-Step Medium Plus2Cleared 510(K)
- K240176V-VITFREEZE and V-VITWARM2Cleared 510(K)
- K233846Vitrification Solution Set and Warming Solution Set2Cleared 510(K)
- K240605Ultra RapidWarm™ Blast2Cleared 510(K)
- K233477Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)2Cleared 510(K)
- K240149Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step Medium2Cleared 510(K)
- K234023Oocyte Flushing & Retrieval Medium; Gamete Buffer2Cleared 510(K)
- K233764SSS-NX (Serum Substitute Supplement-NX)2Cleared 510(K)
- K232125V-PVP2Cleared 510(K)
- K232942G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing Media2Cleared 510(K)
- K231370Dewin Blastocyst Medium (with HSA and without HSA)2Cleared 510(K)
- K222606V-HYADASE2Cleared 510(K)
- K223265CryoX Vitrification Freeze Kit / Thaw Kit2Cleared 510(K)
- K220715ARTSMedia In Vitro Culture Medium (AM-IVC Medium)2Cleared 510(K)
- K223117V-SPERM WASH2Cleared 510(K)
- K213293V-HEPES PLUS2Cleared 510(K)
- K212426Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])2Cleared 510(K)
- K212410VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium2Cleared 510(K)
- K202862Gx-IVF, Gx-TL, Gx-MOPS PLUS2Cleared 510(K)
- K193285V-ONESTEP2Cleared 510(K)
- K192503GM501 Wash with Phenol Red and Gentamicin2Cleared 510(K)
- K200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])2Cleared 510(K)
- K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium2Cleared 510(K)
- K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA2Cleared 510(K)
- K192845Sperm Freeze, Sperm Fridge2Cleared 510(K)
- K200680Synvitro Hyadase2Cleared 510(K)
- K192644GM501 SpermAir and GM501 SpermActive2Cleared 510(K)
- K190199SepaSperm Washing Solution, SepaSperm Solution2Cleared 510(K)
- K191552GM501 Mineral Oil2Cleared 510(K)
- K190383GM501 Wash2Cleared 510(K)
- K1910631-Step Culture Medium2Cleared 510(K)
- K183486RapidVit™ Oocyte, RapidWarm™ Oocyte2Cleared 510(K)
- K190152Vit Kit- Freeze NX and Vit Kit- Warm NX2Cleared 510(K)
- K182002Cumulus Remover2Cleared 510(K)
- K180073Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set2Cleared 510(K)
- K173731SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)2Cleared 510(K)
- K173624ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)2Cleared 510(K)
- K171748Vitrification Kit and Thawing Kit2Cleared 510(K)
- K172197SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS2Cleared 510(K)
- K170498Gems Oocyte Retrieval Buffer ORB-20, ORB-502Cleared 510(K)
- K171224Arctic Sperm Cryopreservation Medium2Cleared 510(K)
- K170681Continuous Single Culture -NX (CSCM-NX)2Cleared 510(K)
- K170602Continuous Single Culture-NX Complete (CSCM-NXC)2Cleared 510(K)
- K162409Gems Vitrification Set, Gems Warming Set2Cleared 510(K)
- K161261Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase2Cleared 510(K)
- K170560SAGE Vitrification Kit and SAGE Vitrification Warming Kit2Cleared 510(K)
- K170257Sydney IVF Culture Oil2Cleared 510(K)
- K160864Cryotop Vitrification Kit and Cryotop Thawing Kit2Cleared 510(K)
- K153478Sydney IVF Gamete Buffer2Cleared 510(K)
- K160863PBS(-), Phosphate Buffered Saline2Cleared 510(K)
- K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash2Cleared 510(K)
- K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit2Cleared 510(K)
- K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit2Cleared 510(K)
- K160006Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit2Cleared 510(K)
- K160814Sydney IVF Sperm Cryopreservation Buffer2Cleared 510(K)
- K160142MINERAL OIL2Cleared 510(K)
- K152932BlastGen2Cleared 510(K)
- K153290Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium2Cleared 510(K)
- K151367Sydney IVF Hyaluronidase2Cleared 510(K)
- K152782SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT2Cleared 510(K)
- K150950FreezeKit Cleave , ThawKit Cleave2Cleared 510(K)
- K152904SYDNEY IVF EMBRYO BIOPSY MEDIUM2Cleared 510(K)
- K152440Sydney IVF PVP2Cleared 510(K)
- K143724COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit2Cleared 510(K)
- K142991LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA2Cleared 510(K)
- K143498LifeGlobal Global HP2Cleared 510(K)
- K133568G-TL2Cleared 510(K)
- K140317EMBRYOGEN2Cleared 510(K)
- K133912ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO2Cleared 510(K)
- K133387ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED2Cleared 510(K)
- K133707SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS2Cleared 510(K)
- K113786SPERMFREEZE SOLUTION2Cleared 510(K)
- K120136EMBRYOGEN2Cleared 510(K)
- K121572CONTINUOUS SINGLE CULTURE COMPLETE2Cleared 510(K)
- K121128MULTIPURPOSE HANDLING MEDIUM2Cleared 510(K)
- K112083LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES2Cleared 510(K)
- K092963GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S32Cleared 510(K)
- K101003RAPIDVIT BLAST, RAPIDWARM BLAST2Cleared 510(K)
- K100367MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 12292Cleared 510(K)
- K092107VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-0102Cleared 510(K)
- K092667GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT2Cleared 510(K)
- K092578LIFEGLOBAL PROTEIN SUPPLEMENT2Cleared 510(K)
- K093273VIT KIT - FREEZE AND THAW2Cleared 510(K)
- K082363COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS2Cleared 510(K)
- K083509LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA2Cleared 510(K)
- K080172BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 12162Cleared 510(K)
- K080446RAPIDVIT AND RAPIDWARM CLEAVE2Cleared 510(K)
- K073522VITRIFICATION KIT & VITRIFICATION WARMING KIT2Cleared 510(K)
- K081639ICSI CUMULASE2Cleared 510(K)
- K081115G-MOPS G5 SERIES2Cleared 510(K)
- K081114G-1 V52Cleared 510(K)
- K081117G-2 V52Cleared 510(K)
- K080473EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED2Cleared 510(K)
- K081116G-IVF G5 SERIES2Cleared 510(K)
- K072609SINGLE STEP MEDIUM2Cleared 510(K)
- K072608LYOPHILIZED MULTIBLAST MEDIUM KIT2Cleared 510(K)
- K072607LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT2Cleared 510(K)
- K070135VITRIFREEZE MEDIUM; VITRITHAW MEDIUM2Cleared 510(K)
- K070689LG SPERM FREEZING2Cleared 510(K)
- K061309EMBRYOASSIST2Cleared 510(K)
- K061145SPERMSLOW2Cleared 510(K)
- K061371SYDNEY IVF SPERM CRYOPRESERVATION BUFFER2Cleared 510(K)
- K060983BIOPSY MEDIUM, MODEL REF 10622Cleared 510(K)
- K053646INVITRO MATURATION MEDIA2Cleared 510(K)
- K053552GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA2Cleared 510(K)
- K060699SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)2Cleared 510(K)
- K053551MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL2Cleared 510(K)
- K060168VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT2Cleared 510(K)
- K053494OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE2Cleared 510(K)
- K042495CUMULASE2Cleared 510(K)
- K043116ICSI-1002Cleared 510(K)
- K041284MEDICULT IVM SYSTEM2Cleared 510(K)
- K040530MEDIA CULTURE SYSTEM2Cleared 510(K)
- K033101G-PGD2Cleared 510(K)
- K032877G-OOCYTE2Cleared 510(K)
- K032154G-FREEZEKIT BLAST2Cleared 510(K)
- K032155G-THAWKIT BLAST2Cleared 510(K)
- K034063MULTIBLAST MEDIUM2Cleared 510(K)
- K031304SYDNEY IVF PVP2Cleared 510(K)
- K033462EARLY CLEAVAGE MEDIUM (ECM)2Cleared 510(K)
- K032887PHENOL RED STOCK SOLUTION2Cleared 510(K)
- K030441SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT2Cleared 510(K)
- K030490ISM1+, IMS2+, AND UTM+2Cleared 510(K)
- K031486BLASTFREEZE AND BLASTTHAW2Cleared 510(K)
- K031228SYNVITRO HYADASE2Cleared 510(K)
- K031015EMBRYOGLUE2Cleared 510(K)
- K030850ENHANCE HUMAN SERUM ALBUMIN2Cleared 510(K)
- K030117ENHANCE SPERM FREEZE2Cleared 510(K)
- K024290PROMOTOR FINAL RINSE SPERM WASH MEDIUM2Cleared 510(K)
- K030116ENHANCE-S PLUS H2Cleared 510(K)
- K023850SYDNEY IVF EMBRYO BIOPSY MEDIUM2Cleared 510(K)
- K023222ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-122Cleared 510(K)
- K023353SYDNEY IVF HYALURONIDASE2Cleared 510(K)
- K023717SPERM WASH MEDIUM WITH GENTAMICIN2Cleared 510(K)
- K023655ENHANCE HTF MEDIUM WITH HEPES2Cleared 510(K)
- K023403SPERMGRAD, MODELS 10022/100632Cleared 510(K)
- K023033ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)2Cleared 510(K)
- K023206SPERM CRYOPROTEC2Cleared 510(K)
- K023106PROMOTOR2Cleared 510(K)
- K022931HYALURONIDASE SOLUTION2Cleared 510(K)
- K022295G-RINSE, MODEL 100312Cleared 510(K)
- K022247G-SPERM, MODEL 100322Cleared 510(K)
- K022245G-FERT, MODEL 100332Cleared 510(K)
- K022244G-1 VERSION 3, MODEL 100482Cleared 510(K)
- K021896HSA-SOLUTION, MODEL 10034/100642Cleared 510(K)
- K021890G-2 VERSION 3, MODEL 100492Cleared 510(K)
- K021893G-MOPS, MODEL 100302Cleared 510(K)
- K021894G-MM, MODEL 100382Cleared 510(K)
- K022590PVP (POLYVINYLPYRROLIDONE)2Cleared 510(K)
- K022547ACIDIFIED TYRODES SOLUTION2Cleared 510(K)
- K022443SPERMASSIST2Cleared 510(K)
- K022352HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)2Cleared 510(K)
- K022334HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS2Cleared 510(K)
- K022330ALLGRAD 45 AND 90 CELL SEPARATION MEDIA2Cleared 510(K)
- K022332LITE MINERAL OIL2Cleared 510(K)
- K022335ALLGRAD AND ALLGRAD1002Cleared 510(K)
- K022002SYDNEY IVF CULTURE OIL2Cleared 510(K)
- K021358EMBRYO BIOPSY MEDIUM2Cleared 510(K)
- K020490PBS, PBSW WITH CATIONS AND PHENOL RED2Cleared 510(K)
- K013518EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM2Cleared 510(K)
- K011607SPERMCATCH2Cleared 510(K)
- K012123NIDOIL2Cleared 510(K)
- K011938OIL FOR EMBRYO CULTURE2Cleared 510(K)
- K011606PURESPERM BUFFER2Cleared 510(K)
- K011573HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM2Cleared 510(K)
- K01148110% PVP; 10% PVP IN EBSS SOLUTION2Cleared 510(K)
- K011346READYSWIM2Cleared 510(K)
- K011462OIL FOR TISSUE CULTURE2Cleared 510(K)
- K011157COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT2Cleared 510(K)
- K010183GLOBAL BY <GENX> BLASTOCYST MEDIA2Cleared 510(K)
- K003404SUPRASPERM SYSTEM2Cleared 510(K)
- K003156BLASTASSIST SYSTEM2Cleared 510(K)
- K003163SYNVITRO FLUSH2Cleared 510(K)
- K003751HYALURONIDASE REAGENT, MODEL CAT#22122Cleared 510(K)
- K003278COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 99222Cleared 510(K)
- K003734SERUM PROTEIN SUBSTITUTE2Cleared 510(K)
- K003448DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 93012Cleared 510(K)
- K002630PURESPERM WASH2Cleared 510(K)
- K002623PURESPERM 40 AND PURESPERM 802Cleared 510(K)
- K002836MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE2Cleared 510(K)
- K002385COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,2Cleared 510(K)
- K002383COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT2Cleared 510(K)
- K001967PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#22102Cleared 510(K)
- K991279MEDI-CULT UNIVERSAL IVF-MEDIUM2Cleared 510(K)
- K000619SCANDINAVIAN IVF SCIENCES AB, G2.22Cleared 510(K)
- K991331MEDI-CULT M3 MEDIUM2Cleared 510(K)
- K991334MEDI-CULT HYALURONIDASE;2Cleared 510(K)
- K001113IVC THREE BLASTOCYST MEDIUM, CAT # 20072Cleared 510(K)
- K000627SCANDINAVIAN IVF SCIENCES AB, HYBASE-12Cleared 510(K)
- K000989SPERM WASH MEDIUM, CAT# 2003/20052Cleared 510(K)
- K000937IVC TWO MEDIUM2Cleared 510(K)
- K000938IVC ONE MEDIUM2Cleared 510(K)
- K993484Q-HTF, CAT# 20012Cleared 510(K)
- K000626SCANDINAVIAN IVF SCIENCES AB, GAMETE-1002Cleared 510(K)
- K000625SCANDINAVIAN IVF SCIENCES AB, G1.22Cleared 510(K)
- K000618SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 12Cleared 510(K)
- K991348IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 25002Cleared 510(K)
- K000623SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 12Cleared 510(K)
- K000621SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/1002Cleared 510(K)
- K991471MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015)2Cleared 510(K)
- K991472MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 10792Cleared 510(K)
- K000939HTF-HEPES2Cleared 510(K)
- K000940HUMAN SERUM ALBUMIN (HSA)2Cleared 510(K)
- K991327MEDI-CULT FLUSHING MEDIUM2Cleared 510(K)
- K991332MEDI-CULT SPERM PREPARATION - MEDIUM;2Cleared 510(K)
- K991380OIL FOR TISSUE CULTURE2Cleared 510(K)
- K000309BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM2Cleared 510(K)
- K991470MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060)2Cleared 510(K)
- K991333MEDI-CULT SPERM FREEZE MEDIUM2Cleared 510(K)
- K991335MEDI-CULT FREEZING & THAWING PACKS2Cleared 510(K)
- K991351OVOIL-150, MODEL 50022Cleared 510(K)
- K991329MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE2Cleared 510(K)
- K991330MEDI-CULT LIQUID PARAFFIN2Cleared 510(K)
- K991346PH-100, MODEL 21042Cleared 510(K)
- K991345ASP-100, MODEL 21002Cleared 510(K)
- K991395QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM2Cleared 510(K)
- K991396WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L2Cleared 510(K)
- K991392HUMAN SERUM ALBUMIN2Cleared 510(K)
- K991393HYALURONIDASE, 80 U/ML2Cleared 510(K)
- K991379QUINN'S SPERM WASHING MEDIUM2Cleared 510(K)
- K9913901.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI2Cleared 510(K)
- K991391PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF2Cleared 510(K)
- K991339TYRODE'S SOLUTION-ACIDIFIED2Cleared 510(K)
- K991381PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA2Cleared 510(K)
- K991378PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED2Cleared 510(K)
- K991419MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI2Cleared 510(K)
- K991022<GENX> SPERM WASHING MEDIA2Cleared 510(K)
- K991322ENHANCE-S PLUS2Cleared 510(K)
- K991173<GENX> FERTILIZATION MEDIA-HTF2Cleared 510(K)
- K991343PVP (POLYVINYLPYRROLIDONE)2Cleared 510(K)
- K991338BOVINE SERUM ALBUMIN (BSA)2Cleared 510(K)
- K991342PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION2Cleared 510(K)
- K991341ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION2Cleared 510(K)
- K991337SPERM MAINTENANCE MEDIUM WITH GLYCEROL2Cleared 510(K)
- K991421FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB)2Cleared 510(K)
- K991420MODIFIED HAM'S F-10 WITH ALBUMIN2Cleared 510(K)
- K983588SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM2Cleared 510(K)
- K983579SYNTHETIC SERUM SUBSTITUTE (SSS)2Cleared 510(K)
- K983589P-1 (PREIMPLANTATION STAGE ONE) MEDIUM2Cleared 510(K)
- K983580BLASTOCYST MEDIUM2Cleared 510(K)
- K983586HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI2Cleared 510(K)
- K983584HUMAN SERUM ALBUMIN (HSA)2Cleared 510(K)
- K984172MODIFICATION OF PURESPERM2Cleared 510(K)
- K980814PURESPERM2Cleared 510(K)
- K971809ISOLATE2Cleared 510(K)
- K864524SPERM SELECT(TM)2Cleared 510(K)
- MRXSystem, Assisted Reproduction Laser2Product Code
- MTWSystem, Water, Reproduction, Assisted, And Purification2Product Code
- MTXMicroscope And Microscope Accessories, Reproduction, Assisted1Product Code
- NNBNeedle, Reproduction, Assisted, Reprocessed2Product Code
- PBHEmbryo Image Assessment System, Assisted Reproduction2Product Code
- OYOCulture, Intravaginal, Assisted Reproduction2Product Code
- PUBAccessory, Assisted Reproduction, Exempt2Product Code
- PUCMicrotools, Assisted Reproduction (Pipettes), Exempt2Product Code
- PUDLabware, Assisted Reproduction, Exempt2Product Code
- QKHAssisted Reproduction Laminar Flow Workstation2Product Code
- QKIMedia, Reproductive, Exempt2Product Code
- QUJAutomated Cryopreservation Storage System2Product Code
- QYZAt Home Intravaginal Insemination System2Product Code
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K161261
- 510(k) Type
- Traditional
- Applicant
- Genea Biomedx Pty Ltd
- Country
- Australia
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/12/2017
- Days to Decision
- 373 days
- Submission Type
- Summary