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
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- GMBLight, Wood'S, Fluorescence1Product Code
- GTLPhages, Staphylococcal Typing, All Types1Product Code
- JRZMedia, Culture, Amino Acid Assay1Product Code
- JSACulture Media, Antibiotic Assay1Product Code
- JSBCulture Media, Vitamin Assay1Product Code
- JSCCulture Media, General Nutrient Broth1Product Code
- JSDCulture Media, Selective Broth1Product Code
- JSECulture Media, Multiple Biochemical Test1Product Code
- JSFCulture Media, Single Biochemical Test1Product Code
- JSGCulture Media, Non-Selective And Non-Differential1Product Code
- JSHCulture Media, Non-Selective And Differential1Product Code
- JSICulture Media, Selective And Differential1Product Code
- JSJCulture Media, Selective And Non-Differential1Product Code
- JSKSupplement, Culture Media1Product Code
- JSLCulture Media, Anaerobic Transport1Product Code
- JSMCulture Media, Non-Propagating Transport1Product Code
- JSNCulture Media, Propagating Transport1Product Code
- JSPKit, Anaerobic Identification1Product Code
- JSRKit, Identification, Dermatophyte1Product Code
- JSSKit, Identification, Enterobacteriaceae1Product Code
- JSTKit, Fastidious Organisms1Product Code
- JSWKit, Identification, Glucose Nonfermenter1Product Code
- JSXKit, Identification, Neisseria Gonorrhoeae1Product Code
- JSYKit, Identification, Mycobacteria1Product Code
- JSZKit, Identification, Pseudomonas1Product Code
- JTAMonitor, Microbial Growth1Product Code
- JTBDevice, Media Dispensing/Stacking1Product Code
- JTCDevice, Microtiter Diluting/Dispensing1Product Code
- JTLPlasma, Coagulase, Human, Horse And Rabbit1Product Code
- JTMAnaerobic Box Glove1Product Code
- JTODiscs, Strips And Reagents, Microorganism Differentiation1Product Code
- JTQBath, Incubators/Water, All1Product Code
- JTRKit, Quality Control For Culture Media1Product Code
- JTWSystem, Transport, Aerobic1Product Code
- JTXTransport Systems, Anaerobic1Product Code
- JTYCulture Media, For Isolation Of Pathogenic Neisseria2Product Code
- JWXKit, Screening, Staphylococcus Aureus1Product Code
- JWZKit, Screening, Trichomonas1Product Code
- JXAKit, Screening, Urine1Product Code
- JXBKit, Identification, Yeast1Product Code
- JXCKit, Screening, Yeast1Product Code
- KZBAutomated Colony Counter1Product Code
- KZCManual Colony Counter1Product Code
- KZICulture Media, Enriched1Product Code
- K884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)1Cleared 510(K)
- K881995DIAMOND'S MEDIUM MODIFIED1Cleared 510(K)
- K880134MIDDLEBROOK 7H11 AGAR1Cleared 510(K)
- K880131LOWENSTEIN-JENSEN, GRUFT1Cleared 510(K)
- K880122MIDDLEBROOK 7H9 BROTH1Cleared 510(K)
- K880138WALLENSTEIN MEDIUM SLANT1Cleared 510(K)
- K880109CYSTINE TRYPTIC MEDIUM BASE1Cleared 510(K)
- K880127POTATO DEXTROSE AGAR1Cleared 510(K)
- K874179BIOTIS (TM) SABHI (DOUBLE POUR)1Cleared 510(K)
- K874177BIOTIS (TM) BCYE1Cleared 510(K)
- K873267ECG BASED MEDIA1Cleared 510(K)
- K873266MIDDLEBROOK BASED MEDIA1Cleared 510(K)
- K873952MICRO CULTURE MEDIA P3141, P3136, P3148, P37481Cleared 510(K)
- K873321SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T43001Cleared 510(K)
- K873320SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD1Cleared 510(K)
- K873061TRYPTIC SOY AGAR W/5% SHEEP BLOOD - #T14051Cleared 510(K)
- K873058TRYPTIC SOY AGAR (TSA) W/5% HORSE BLOOD #P28101Cleared 510(K)
- K873060TRYPTIC SOY AGAR W/5% SHEEP BLOOD - PRODUCT P10021Cleared 510(K)
- K872685IAFP LOWENSTEIN JENSEN SLANT1Cleared 510(K)
- K872671IAFP T.S.A. W/5% SHEEP BLOOD1Cleared 510(K)
- K872678IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K11Cleared 510(K)
- K872193FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU1Cleared 510(K)
- K870634TETRATHIONATE BROTH1Cleared 510(K)
- K870642COOKED MEAT MEDIUM WITH IRON1Cleared 510(K)
- K870646MIDDLEBROOK 7H10 AGAR1Cleared 510(K)
- K871092HORSE BLOOD AGAR, ENRICHED1Cleared 510(K)
- K864238CHOCOLATE AGAR1Cleared 510(K)
- K864014LOMBARD DOWELL AGAR BASE1Cleared 510(K)
- K862761VACUTAINER BRAND AGAR SLANT1Cleared 510(K)
- K862390BIOTIS BORDET GENGOU AGAR1Cleared 510(K)
- K860410BIOTIS COOKED MEAT1Cleared 510(K)
- K854454TRYPTIC SOY BLOOD AGAR1Cleared 510(K)
- K854228COLUMBIA 5% BLOOD AGAR1Cleared 510(K)
- K854064BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR1Cleared 510(K)
- K853233APL CHOCOLATE AGAR1Cleared 510(K)
- K853236APL TSA WITH 5% SHEEP BLOOD1Cleared 510(K)
- K851600TRYPTIC SOY AGAR W/5% SHEEP BLOOD1Cleared 510(K)
- K851588CHOCOLATE AGAR1Cleared 510(K)
- K850724CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL1Cleared 510(K)
- K850735ENRICHED CULTURE MEDIUM1Cleared 510(K)
- K843065BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG1Cleared 510(K)
- K841749CHOCOLATE AGAR1Cleared 510(K)
- K841748SHEEP BLOOD AGAR1Cleared 510(K)
- K841586CHOCOLATE AGAR1Cleared 510(K)
- K841837ENRICHED CULTURE MED. FLUID THIOGLYC01Cleared 510(K)
- K841838ENRICHED CULTURE MED. TRYPTIC SOY AGAR1Cleared 510(K)
- K832533SELENITE CYSTINE BROTH1Cleared 510(K)
- K830383FILDES ENRICHMENT SOLUTON1Cleared 510(K)
- K830074CHOCOLATE AGAR, ENRICHED1Cleared 510(K)
- K830078BLOOD AGAR(TSA W/5% SHEEP BLOOD)1Cleared 510(K)
- K820563THIOGLYCOLLATE ENRICHED1Cleared 510(K)
- KZJDevice, Gas Generating1Product Code
- KZKReader, Zone, Automated1Product Code
- LGADevice, Oxidase Test For Gonorrhea3Product Code
- LIBDevice, General Purpose, Microbiology, Diagnostic1Product Code
- LIODevice, Specimen Collection1Product Code
- LJFDevice, Antimicrobial Drug Removal1Product Code
- LJGQuality Control Slides1Product Code
- LKSDevice, Parasite Concentration1Product Code
- LLHReagents, Clostridium Difficile Toxin1Product Code
- LQLGram Positive Identification Panel1Product Code
- LQMGram Negative Identification Panel1Product Code
- LRHInstrument For Auto Reader Of Overnight Microorganism Identification System1Product Code
- LSCNeisseria Controls1Product Code
- LTSTest Reagents, Neisseria Gonorrhoeae Biochemical1Product Code
- MCBAntigen, C. Difficile1Product Code
- MDBSystem, Blood Culturing1Product Code
- MJKDna Probe, Trichomonas Vaginalis1Product Code
- MJMDna Probe, Gardnerella Vaginalis1Product Code
- MLADna Probe, Yeast1Product Code
- NZSFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast1Product Code
- OMNC. Difficile Nucleic Acid Amplification Test Assay1Product Code
- OUSMethicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt1Product Code
- PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System2Product Code
- PPUMicrobial Colony Image Assessment System2Product Code
- PQZGbs Culture Media, Selective And Differential1Product Code
- QBDMicrobial Nucleic Acid Storage And Stabilization Device2Product Code
- QBQSystem, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture1Product Code
- QMCTransport Medium, Notified Per The Vtm Guidance1Product Code
- QQYCulture Plate Imaging System For Qualitative Assessment Of Resistant Organisms2Product Code
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
FILDES ENRICHMENT SOLUTON
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K830383
- 510(k) Type
- Traditional
- Applicant
- GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/8/1983
- Days to Decision
- 32 days