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
2737–2760 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 18, 1996
M. CAT BUTYRATE DISK
K960996 · JTO
Hardy Diagnostics
Microbiology · 37d
Cleared Apr 15, 1996
RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
K951359 · LFX
Bayer Corp.
Microbiology · 385d
Cleared Apr 15, 1996
CARDS Q.S. STREP A
K955108 · GTZ
Quidel Corp.
Microbiology · 159d
Cleared Apr 10, 1996
HAEMOPHILUS TEST MEDIUM (HTM)
K952595 · JSO
Clinical Standards Laboratories, Inc.
Microbiology · 309d
Cleared Apr 09, 1996
ACCESS RUBELLA IGG
K954687 · LFX
Bio-Rad Laboratories, Inc.
Microbiology · 181d
Cleared Apr 09, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960366 · LTT
Accumed Intl., Inc.
Microbiology · 75d
Cleared Apr 05, 1996
CEFEPIME, 30 MCG, SENSI-DISC
K961188 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 10d
Cleared Apr 04, 1996
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K960420 · JTZ
Becton Dickinson Microbiology Systems
Microbiology · 66d
Cleared Apr 03, 1996
STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
K960997 · LIO
Starplex Scientific, Inc.
Microbiology · 22d
Cleared Mar 27, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960235 · JWY
Accumed Intl., Inc.
Microbiology · 70d
Cleared Mar 25, 1996
MUELLER HINTON AGAR WITH 2% NACI
K960313 · JTZ
Remel, L.P.
Microbiology · 63d
Cleared Mar 22, 1996
BINAX STREP A TEST
K960712 · GTZ
Binax, Inc.
Microbiology · 30d
Cleared Mar 20, 1996
VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951799 · GQX
Light Diagnostics
Microbiology · 336d
Cleared Mar 19, 1996
CALCOFLUOR WHITE STAIN KIT
K960090 · JTS
Remel Co.
Microbiology · 68d
Cleared Mar 19, 1996
BACTIDROP CALCOFLUOR WHITE
K960095 · JTS
Remel Co.
Microbiology · 68d
Cleared Mar 14, 1996
VARICELISA, MODIFICATION
K943843 · LFY
Biowhittaker Molecular Applications,...
Microbiology · 595d
Cleared Mar 12, 1996
VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
K952095 · LQL
Biomerieux Vitek, Inc.
Microbiology · 313d
Cleared Mar 12, 1996
SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM
K960129 · GRM
Sa Scientific, Inc.
Microbiology · 61d
Cleared Mar 12, 1996
SAS SALMONELLA O GROUP Z FACTOR 50 ANTISERUM
K960130 · GRM
Sa Scientific, Inc.
Microbiology · 61d
Cleared Mar 12, 1996
SAS SALMONELLA 0 GROUP E FACTORS 1,3,10,15,19,34 ANTISERUM
K960147 · GRM
Sa Scientific, Inc.
Microbiology · 61d
Cleared Mar 12, 1996
SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM
K960160 · GRM
Sa Scientific, Inc.
Microbiology · 61d
Cleared Mar 12, 1996
SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM
K960461 · GRM
Sa Scientific, Inc.
Microbiology · 42d
Cleared Mar 11, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960220 · JWY
Sensititre , Ltd.
Microbiology · 55d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 18 ANTISERUM &/OR SAS SALMONELLA O GROUP K FACTOR 18...
K960123 · GRM
Sa Scientific, Inc.
Microbiology · 55d