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
- 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
- K193490SensiTox C. difficile Toxin Test1Cleared 510(K)
- K102242OSOM C. DIFFICILE TOXIN A/B TEST1Cleared 510(K)
- K091109XPERT C. DIFFICILE1Cleared 510(K)
- K090239PROGASTRO CD ASSAY1Cleared 510(K)
- K082499C. DIFF QUIK CHEK COMPLETE1Cleared 510(K)
- K081920BD GENEOHM CDIFF ASSAY1Cleared 510(K)
- K080931VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY1Cleared 510(K)
- K072138VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 1181Cleared 510(K)
- K050891TOX A/B QUICK CHEK1Cleared 510(K)
- K041951XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B1Cleared 510(K)
- K041003IMMUNOCARD TOXINS A & B, MODEL 7120501Cleared 510(K)
- K032897C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-961Cleared 510(K)
- K033479PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY1Cleared 510(K)
- K030991C. DIFF CHEK - 301Cleared 510(K)
- K030992C. DIFF CHEK - 601Cleared 510(K)
- K030404C. DIFFICILE TOX A/B II1Cleared 510(K)
- K003306C. DIFFICILE TOX A/B II1Cleared 510(K)
- K993914PREMIER TOXINS A&B, MODEL 6160961Cleared 510(K)
- K991829CDTOX A OIA1Cleared 510(K)
- K990664PRIMA SYSTEM - OLD, BARTELS ELISA - NEW1Cleared 510(K)
- K980185COLORPAC TOXIN A1Cleared 510(K)
- K971182TOX A/B TEST1Cleared 510(K)
- K964887VIDAS C. DIFFICILE TOXIN A II ASSAY1Cleared 510(K)
- K964864PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY1Cleared 510(K)
- K955859IMMUNOCARD TOXIN A1Cleared 510(K)
- K934493PROSPECT MICROPLATE ASSAY1Cleared 510(K)
- K935296CLOSTRIDIUM DIFFICILE TOX-B TEST1Cleared 510(K)
- K931129TECHLAB 1-HOUR TOX-A-TEST1Cleared 510(K)
- K925329CULTURETTE BRAND TOXIN CD TEST1Cleared 510(K)
- K923463CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT1Cleared 510(K)
- K926442PREMIER C. DIFFICILE, MODIFICATION1Cleared 510(K)
- K924979IMMUNOCARD(TM) C. DIFFICILE1Cleared 510(K)
- K924136PREMIER C. DIFFICILE TOXIN A CONTROLS1Cleared 510(K)
- K914902CLOSTRIDIUM DIFFICILE TOX-A-TEST1Cleared 510(K)
- K905211VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY1Cleared 510(K)
- K913229BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN1Cleared 510(K)
- K911958CYTOCLONE A & B EIA1Cleared 510(K)
- K903456PREMIER-C. DIFFICILE TOXIN A1Cleared 510(K)
- K883560CDT CYTOTOXI TEST1Cleared 510(K)
- K870864CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST1Cleared 510(K)
- K863485MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST1Cleared 510(K)
- K852044CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI1Cleared 510(K)
- 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
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K033479
- 510(k) Type
- Traditional
- Applicant
- Remel, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/26/2004
- Days to Decision
- 115 days
- Submission Type
- Summary