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
6241–6264 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 04, 1982
CHE
K813611 · JSC
Dms Laboratories
Microbiology · 37d
Cleared Feb 04, 1982
STAPH TRAC
K813614 · JWX
Dms Laboratories
Microbiology · 37d
Cleared Feb 04, 1982
CHL
K813615 · JSC
Dms Laboratories
Microbiology · 37d
Cleared Jan 29, 1982
NEISSERIA GONORRHOEAE TEST
K820007 · LIC
New Horizons Diagnostics Co.
Microbiology · 25d
Cleared Jan 29, 1982
PIPERACILLIN 100MCG. ANTIMICROBIAL
K820019 · JTN
General Diagnostics
Microbiology · 24d
Cleared Jan 28, 1982
GAS GENERATING KIT, CO2
K820010 · KZJ
Oxoid U.S.A., Inc.
Microbiology · 23d
Cleared Jan 28, 1982
CAMPYLOBACTER THIOGLYCOLLATE MED W/5
K820060 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 17d
Cleared Jan 28, 1982
SUSCEPTROL
K820064 · JTR
American Type Culture Collection
Microbiology · 17d
Cleared Jan 26, 1982
TOXOELISA TEST KIT
K813221 · LGD
M.A. Bioproducts
Microbiology · 78d
Cleared Dec 31, 1981
SYSTEK #1 EIKEN
K813164 · JSS
Syn-Kit, Inc.
Microbiology · 51d
Cleared Dec 31, 1981
MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL
K813359 · GMJ
American Scientific Products
Microbiology · 31d
Cleared Dec 31, 1981
CELLULOSE ACETATE-CITRATE AGAR HEMOGLO
K813395 · JBD
Helena Laboratories
Microbiology · 27d
Cleared Dec 31, 1981
PIPERACILLIN 100 MCG. SENSI DISC
K813441 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 21d
Cleared Dec 31, 1981
METRONIDAZOLE DIAGNOSTIC DISCS
K813509 · JTO
Oxoid U.S.A., Inc.
Microbiology · 16d
Cleared Dec 30, 1981
BBL DIRECTIGEN TEST KIT
K812808 · GTY
Bd Becton Dickinson Vacutainer...
Microbiology · 85d
Cleared Dec 29, 1981
METRONIDAZOLE 80MCG. SENSI-DISC
K813387 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 27d
Cleared Dec 29, 1981
CEFINASE TM DISCS
K813442 · JTO
Bd Becton Dickinson Vacutainer...
Microbiology · 19d
Cleared Dec 29, 1981
MRI TOBRAMYCIN RIA KIT
K813516 · KLB
Microanalytic Research, Inc.
Microbiology · 14d
Cleared Dec 22, 1981
BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL
K813349 · DIF
Stanbio Laboratory
Microbiology · 25d
Cleared Dec 18, 1981
DIRECT FA CONJUGATE FOR LEGIONELLA SP
K813339 · LHL
Springwood Microbiologicals
Microbiology · 24d
Cleared Dec 17, 1981
ACU-SLIDE TEST
K812789 · JHJ
C.F. Medical, Inc.
Microbiology · 73d
Cleared Dec 17, 1981
MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK
K812994 · JTN
General Diagnostics
Microbiology · 52d
Cleared Dec 17, 1981
MS-2 BACTERIAL IDENTIFICATION SYS
K813031 · JTO
Abbott Laboratories
Microbiology · 50d
Cleared Dec 08, 1981
UROPAPER EIKEN UHAG
K811816 · JIL
Syn-Kit, Inc.
Microbiology · 165d