FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
6553–6576 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 31, 1980
PHADEBACT PNEUMOCOCCUS TEST
K802337 · GWC
Pharmacia, Inc.
Microbiology · 35d
Cleared Oct 31, 1980
BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT
K802415 · JSG
Remel Co.
Microbiology · 25d
Cleared Oct 31, 1980
LA-SPORO ANTIBODY SYSTEM
K802427 · GMA
Immuno-Mycologics, Inc.
Microbiology · 25d
Cleared Oct 31, 1980
HI VOLUME PUMPING CHAMBER
K802561 · JTB
Acacia, Inc.
Microbiology · 15d
Cleared Oct 31, 1980
TRANSETTE SYSTEM/COLLECTION & TRANSP
K802563 · JTW
Inolex Corp./Div of Biomedical
Microbiology · 15d
Cleared Oct 31, 1980
BETA LACTAMASE REAGENT DISK
K802566 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 14d
Cleared Oct 23, 1980
GAMMA COAT(125 I) RUBELLA ANTIBODY
K801667 · GOL
Clinical Assays, Inc.
Microbiology · 94d
Cleared Oct 23, 1980
FTA-ABS TEST
K801959 · JWL
Immuno-Diagnostic Products, Inc.
Microbiology · 65d
Cleared Oct 23, 1980
CMV TEST KIT
K801963 · GQH
Immuno-Diagnostic Products, Inc.
Microbiology · 65d
Cleared Oct 23, 1980
MINOCYCLINE 30MCG. SENSI DISC
K802194 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 43d
Cleared Oct 23, 1980
FTA-ABS BIOPAK
K802276 · JWL
Bioware Products
Microbiology · 35d
Cleared Oct 23, 1980
ANAEROBE BLOOD AGAR
K802397 · JSG
Granite Diagnostics, Inc.
Microbiology · 21d
Cleared Oct 23, 1980
E-VAC BLOOD CULTURE SYSTEM
K802408 · JSC
Pfizer Pharmaceuticals
Microbiology · 20d
Cleared Oct 10, 1980
SERO STREP KIT
K801775 · GTZ
Sacks Farms Biological Products
Microbiology · 74d
Cleared Oct 10, 1980
MINOCYCLINE 30 MCG. SENSITIVITY DISCS
K802178 · JTN
Difco Laboratories, Inc.
Microbiology · 31d
Cleared Sep 26, 1980
API-CTS STREPTOCOCCUS
K801951 · JTO
Analytical Products, Inc.
Microbiology · 39d
Cleared Sep 26, 1980
IMMUNODIFFUSSION REAGENTS/SEROLOGICAL
K802128 · JWW
Nolan Biological Laboratories, Inc.
Microbiology · 53d
Cleared Sep 26, 1980
IMMUNODIFFUSION REAGENTS/SEROLOGICAL
K802129 · GMI
Nolan Biological Laboratories, Inc.
Microbiology · 53d
Cleared Sep 26, 1980
IMMUNO. IDENTIFICATION OF H. CAPSULATUM
K802130 · GMJ
Nolan Biological Laboratories, Inc.
Microbiology · 53d
Cleared Sep 16, 1980
ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)
K801098 · GOL
Flow Laboratories, Inc.
Microbiology · 130d
Cleared Sep 16, 1980
TOXO BIO-BEAD TITRATION KIT
K801720 · GLZ
Litton Bionetics
Microbiology · 55d
Cleared Sep 16, 1980
HSV BIO-BEAD TITRATION KIT
K801721 · GQN
Litton Bionetics
Microbiology · 55d
Cleared Sep 16, 1980
CMV BIO-BEAD TITRATION KIT
K801722 · GQH
Litton Bionetics
Microbiology · 55d
Cleared Sep 16, 1980
STREP B POLYVALENT FLUORO-KIT
K801876 · GTX
Clinical Sciences, Inc.
Microbiology · 42d