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
4513–4536 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 07, 1987
CARIESCREEN LB
K871264 · JSJ
Apo Diagnostics, Inc.
Microbiology · 37d
Cleared Apr 29, 1987
CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT
K864128 · LJP
Diagnostic Technology, Inc.
Microbiology · 190d
Cleared Apr 29, 1987
CHLAMYDIAZYME DIAGNOSTIC KIT
K864842 · LJC
Abbott Laboratories
Microbiology · 140d
Cleared Apr 29, 1987
BROTH ELUTION DISKS CLINDAMYCIN 10MCG
K870175 · JTN
Difco Laboratories, Inc.
Microbiology · 104d
Cleared Apr 29, 1987
DISPENS-O-DISC BROTH ELUTION DISKS METRON. 80 MCG
K870201 · JTN
Difco Laboratories, Inc.
Microbiology · 99d
Cleared Apr 29, 1987
MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST
K870946 · LJP
Serono Diagnostics, Inc.
Microbiology · 51d
Cleared Apr 29, 1987
CONTROLCHEK(TM)
K871445 · JTO
Petra Biomedical Products, Inc.
Microbiology · 16d
Cleared Apr 29, 1987
MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226
K871541 · JTY
Gibco Laboratories Life Technologies,...
Microbiology · 9d
Cleared Apr 28, 1987
TOXOPLASMA IGM MICROASSAY
K870753 · LGD
Diamedix Corp.
Microbiology · 61d
Cleared Apr 28, 1987
BACTO(R) STREP GROUP KIT
K870854 · GTZ
Difco Laboratories, Inc.
Microbiology · 56d
Cleared Apr 22, 1987
ENZYGNOST ANTI-VZV IGG TEST
K863317 · GQX
Behring Diagnostics, Inc.
Microbiology · 239d
Cleared Apr 22, 1987
BACTIGEN SALMONELLA-SHIGELLA TEST
K870813 · GRM
Armkel, LLC
Microbiology · 50d
Cleared Apr 21, 1987
RAPID AS LATEX
K862530 · GTQ
Dilab, Inc.
Microbiology · 293d
Cleared Apr 21, 1987
CHROMAGEN TEST FOR GROUP D ENTEROCOCCUS
K870410 · JTO
Diversified Diagnostic Industries
Microbiology · 77d
Cleared Apr 21, 1987
GEN-PROBE BETA-LACTAMASE TEST KIT
K870422 · JTO
Gen-Probe, Inc.
Microbiology · 77d
Cleared Apr 21, 1987
CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION
K870561 · JTO
Diversified Diagnostic Industries
Microbiology · 70d
Cleared Apr 21, 1987
KULTSURE
K871404 · JSM
Ncs Diagnostics, Inc.
Microbiology · 13d
Cleared Apr 20, 1987
LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST
K864006 · LHL
Medical Diagnostic Technologies, Inc.
Microbiology · 187d
Cleared Apr 20, 1987
GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA
K864597 · LQF
Gen-Probe, Inc.
Microbiology · 147d
Cleared Apr 20, 1987
IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
K864998 · JSM
Boots-Celltech Diagnostics, Inc.
Microbiology · 119d
Cleared Apr 15, 1987
CHROMAGEN TEST FOR GROUP A STREP
K870409 · JTO
Diversified Diagnostic Industries
Microbiology · 71d
Cleared Apr 14, 1987
FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES
K863798 · LKQ
Whittaker Bioproducts, Inc.
Microbiology · 197d
Cleared Apr 14, 1987
RUBELLA MICROASSAY
K864602 · LFX
Diamedix Corp.
Microbiology · 141d
Cleared Apr 14, 1987
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
K870074 · JWY
Microscan Div. Baxter Healthcare Corp.
Microbiology · 96d