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
3457–3480 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 23, 1991
BACTIDROP(TM) OXIDASE
K913008 · JTO
Remel Co.
Microbiology · 77d
Cleared Sep 23, 1991
QTEST INFLUENZA A
K913828 · GNT
Bd Becton Dickinson Vacutainer...
Microbiology · 28d
Cleared Sep 19, 1991
BACTIDROP (TM) NITRATE B
K913010 · JTO
Remel Co.
Microbiology · 73d
Cleared Sep 19, 1991
BACTIDROP(TM) NITRATE A
K913011 · JTO
Remel Co.
Microbiology · 73d
Cleared Sep 18, 1991
BACTIDROP(TM) DESOXYCHOLATE (10%)
K913001 · JTO
Remel Co.
Microbiology · 72d
Cleared Sep 18, 1991
BACTIDROP(TM) SPOT INDOLE
K913004 · JTO
Remel Co.
Microbiology · 72d
Cleared Sep 18, 1991
BACTIDROP(TM) INDOLE (KOVACS)
K913009 · JTO
Remel Co.
Microbiology · 72d
Cleared Sep 16, 1991
QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
K912442 · LYR
Quidel Corp.
Microbiology · 105d
Cleared Sep 16, 1991
GULL ELISAWARE
K912558 · LIB
Gull Laboratories, Inc.
Microbiology · 97d
Cleared Sep 13, 1991
DIPSTICK SALMONELLA
K910438 · GRM
Ampcor, Inc.
Microbiology · 225d
Cleared Sep 10, 1991
DSL BETA 2 MICROGLOBULIN (DSL 6200)
K911881 · JZG
Diagnostic Systems Laboratories, Inc.
Microbiology · 134d
Cleared Sep 06, 1991
API UNISCEPT KB
K912965 · JWY
Analytab Products, Inc.
Microbiology · 60d
Cleared Sep 05, 1991
CRYPTOSPORIDIUM ANTIGEN DETECTION
K905598 · MHJ
Lmd Laboratories
Microbiology · 266d
Cleared Aug 30, 1991
LYME-SPOT IF KIT
K910230 · LSR
Vitek Systems, Inc.
Microbiology · 224d
Cleared Aug 30, 1991
RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM
K911444 · LFX
Wampole Laboratories
Microbiology · 151d
Cleared Aug 29, 1991
API UNISCEPT MIC/UNISCEPT MICRO-MIC
K912964 · JWY
Analytab Products, Inc.
Microbiology · 52d
Cleared Aug 29, 1991
BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN
K913229 · LLH
Baxter Diagnostics, Inc.
Microbiology · 38d
Cleared Aug 23, 1991
BBL(R) DMACA INDOLE REAGENT DROPPERS
K912480 · JTO
Bd Becton Dickinson Vacutainer...
Microbiology · 81d
Cleared Aug 22, 1991
GAP-IGG
K900343 · LYR
Biomerica, Inc.
Microbiology · 576d
Cleared Aug 22, 1991
GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)
K912613 · JWY
Sensititre Microbiology A Div. of...
Microbiology · 71d
Cleared Aug 22, 1991
BACTI-SWAB(TM) NPG
K912832 · LIO
Remel Co.
Microbiology · 57d
Cleared Aug 22, 1991
JUSTONE(TM)
K912846 · JWY
Sensititre Microbiology A Div. of...
Microbiology · 71d
Cleared Aug 12, 1991
SLIDEX MENINGITE-KIT 5
K910210 · GTJ
Vitek Systems, Inc.
Microbiology · 209d
Cleared Aug 12, 1991
CELLABS GIARDIA CEL I.F. TEST
K912152 · MHI
Celltech Diagnostics , Ltd.
Microbiology · 89d