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
3289–3312 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 14, 1992
RAPID NFT, MODIFICATION
K922768 · JSW
Biomerieux Vitek, Inc.
Microbiology · 128d
Cleared Oct 13, 1992
API UNISCEPT KB/TYPE 2 AND 3
K922926 · JWY
Analytical Products, Inc.
Microbiology · 118d
Cleared Oct 05, 1992
SALMONELLA O GROUPING ANTISERA SET
K912791 · GRM
S.M.I. Medical, Inc.
Microbiology · 468d
Cleared Oct 05, 1992
HSV-1 IGM ELISA TEST -- MODIFICATION
K922758 · LGC
Gull Laboratories, Inc.
Microbiology · 119d
Cleared Oct 05, 1992
HSV-2 IGM ELISA TEST--MODIFICATION
K922759 · LGC
Gull Laboratories, Inc.
Microbiology · 119d
Cleared Oct 05, 1992
INDOXYL ACETATE DISK
K923700 · JTO
Remel Co.
Microbiology · 73d
Cleared Oct 05, 1992
PREMIER BLASTOMYCES
K923859 · MJL
Meridian Diagnostics, Inc.
Microbiology · 66d
Cleared Oct 01, 1992
MICRO TRAK XL SYSTEM
K921747 · LJC
Syva Co.
Microbiology · 171d
Cleared Sep 28, 1992
DIASLIDE URINE CULTURING DEVICE
K921045 · JXA
Savyon Diagnostics , Ltd.
Microbiology · 208d
Cleared Sep 28, 1992
BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA
K922583 · LGC
Baxter Diagnostics, Inc.
Microbiology · 124d
Cleared Sep 28, 1992
SLIDEX STAPH-KIT
K923212 · JWX
Biomerieux Vitek, Inc.
Microbiology · 89d
Cleared Sep 28, 1992
PRECISE STREP A
K923673 · GTZ
Becton Dickinson Advanced Diagnostics
Microbiology · 68d
Cleared Sep 28, 1992
LAP DISK
K923827 · JTO
Remel Co.
Microbiology · 60d
Cleared Sep 25, 1992
SYVA MICROTRAK CHLAMYDIA EIA
K920503 · LJC
Syva Co.
Microbiology · 233d
Cleared Sep 25, 1992
MICROTRAK(R) II CHLAMYDIA EIA ASSAY
K921462 · LJC
Syva Co.
Microbiology · 182d
Cleared Sep 25, 1992
AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA
K922457 · MJK
Microprobe Corp.
Microbiology · 122d
Cleared Sep 25, 1992
AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS
K923133 · MJM
Microprobe Corp.
Microbiology · 88d
Cleared Sep 22, 1992
MICROBACT SOLID PLATE SYSTEMS
K923342 · JJS
Radiometer America, Inc.
Microbiology · 98d
Cleared Sep 18, 1992
BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA
K922584 · LGC
Baxter Diagnostics, Inc.
Microbiology · 114d
Cleared Sep 18, 1992
TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL
K922723 · GTQ
Simplicity Diagnostics, Inc.
Microbiology · 105d
Cleared Sep 18, 1992
ENOXACIN 10 MCG. SENSI SISC
K923952 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 43d
Cleared Sep 17, 1992
BARTELS RUBELLA IGM EIA
K922581 · LFX
Baxter Diagnostics, Inc.
Microbiology · 113d
Cleared Sep 17, 1992
BARTELS RUBELLA IGG EIA
K922586 · LFX
Baxter Diagnostics, Inc.
Microbiology · 113d
Cleared Sep 14, 1992
OPUS(R) TOXO-G TEST SYSTEM
K921523 · LGD
Pb Diagnostics, Inc.
Microbiology · 167d