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
6601–6624 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 08, 1980
NITRATE SWAB-RAPID TEST
K800803 · JXB
Remel Co.
Microbiology · 89d
Cleared Jul 08, 1980
HIPPUR-ASE TUBES
K800816 · JTO
Microchemical Specialities, Co.
Microbiology · 88d
Cleared Jul 08, 1980
ASO QUANTUM, ANTISTREPTOLYSIN O TEST
K801177 · GTQ
Sclavo, Inc.
Microbiology · 53d
Cleared Jun 30, 1980
RUBELLA BIO-BEAD TITRATION KIT
K800789 · GOL
Litton Bionetics
Microbiology · 83d
Cleared Jun 20, 1980
MACRO-VUE RUBELLA CARD TEST
K800797 · GOL
Bd Becton Dickinson Vacutainer...
Microbiology · 72d
Cleared Jun 20, 1980
STREPTO-SEC TM
K801159 · GTZ
Organon, Inc.
Microbiology · 40d
Cleared Jun 02, 1980
CAPIK-CANDIDA ALBICANS IDENT. KIT.
K800908 · JXB
Immuno-Mycologics, Inc.
Microbiology · 42d
Cleared Jun 02, 1980
TRYPTICASE SOY AGAR W5% SHEEP BLOOD
K800986 · JSG
Quality Assurance Laboratory, Inc.
Microbiology · 40d
Cleared Jun 02, 1980
MUELLER HINTON AGAR
K800987 · JTZ
Quality Assurance Laboratory, Inc.
Microbiology · 40d
Cleared Jun 02, 1980
DYNAWASHER II
K800989 · JTC
Dynatech Laboratories, Inc.
Microbiology · 39d
Cleared May 28, 1980
XYLOSE LYSINE DESOXYCHOLATE AGAR
K800978 · JSH
Quality Assurance Laboratory, Inc.
Microbiology · 35d
Cleared May 28, 1980
CHOCOLATE AGAR W/ENRICHMENTS
K800981 · JSG
Quality Assurance Laboratory, Inc.
Microbiology · 35d
Cleared May 23, 1980
LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE
K800899 · KZJ
Miles Laboratories, Inc.
Microbiology · 35d
Cleared May 23, 1980
THAYER-MARTIN AGAR
K800977 · JTY
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
MUELLER HINTIN AGAR W/5% SHEEP BLOOD
K800979 · JTZ
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
HEXTOEN ENTERIC AGAR
K800980 · JSI
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
SALMONELLA SHIGELLA AGAR
K800982 · JSH
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
MACCONKEY AGAR
K800983 · JSI
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
EOSIN METHYLENE BLUE AGAR, LEVINE
K800984 · JSH
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
THIOGLYCOLLATE MED. W/O INDICATOR
K800985 · JSG
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 20, 1980
VIRAL CULTURETTE HANK'S BAL. SALT SOL.
K800832 · JSM
Marion Health & Safety, Inc.
Microbiology · 36d
Cleared May 08, 1980
RAPID FERMENTATION AGAR (RFA)
K800734 · JSE
Remel Co.
Microbiology · 36d
Cleared May 02, 1980
CELLIBIOSE-ARGININE-LYSINE AGAR (CAL)
K800745 · JSI
Remel Co.
Microbiology · 29d
Cleared Apr 29, 1980
PHADEBACT STREP D TEST
K800159 · GTZ
Pharmacia, Inc.
Microbiology · 96d