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
3217–3240 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 23, 1993
NITRATE REAGENTS A, B AND C
K930717 · JTO
Hardy Diagnostics
Microbiology · 71d
Cleared Apr 23, 1993
INDOLE SPOT & INDOLE KOVACS REAGENT
K930718 · JTO
Hardy Diagnostics
Microbiology · 71d
Cleared Apr 23, 1993
VOGUES-PROSKAUER REAGENT A & B
K930720 · JTO
Hardy Diagnostics
Microbiology · 71d
Cleared Apr 21, 1993
PROSPEC T GIARDIA MICROTITER ASSAY
K930451 · MHI
Alexon, Inc.
Microbiology · 84d
Cleared Apr 08, 1993
BARTELS CYTOMEGALOVIRUS IGM EIA
K922580 · LKQ
Baxter Diagnostics, Inc.
Microbiology · 316d
Cleared Apr 08, 1993
BARTELS CYTOMEGALOVIRUS IGG EIA
K922582 · LFZ
Baxter Diagnostics, Inc.
Microbiology · 316d
Cleared Apr 08, 1993
THREE SPIKE CUP
K922870 · GRF
Osteo Technology, Inc.
Microbiology · 308d
Cleared Apr 08, 1993
OPUS SEROLOGY CONTROLS
K925703 · MJX
Pb Diagnostics, Inc.
Microbiology · 147d
Cleared Apr 06, 1993
QUIKPAC STREP A TEST
K924007 · GTZ
Syntron Bioresearch, Inc.
Microbiology · 239d
Cleared Apr 05, 1993
ROCHE OXI/FERM II
K923313 · LQM
Roche Diagnostic Systems, Inc.
Microbiology · 272d
Cleared Apr 05, 1993
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K930055 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 89d
Cleared Apr 02, 1993
CMV ELISA TEST SYSTEM
K924096 · LFZ
Zeus Scientific, Inc.
Microbiology · 232d
Cleared Mar 26, 1993
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K926545 · JWY
Baxter Diagnostics, Inc.
Microbiology · 85d
Cleared Mar 24, 1993
CULTURETTE BRAND TOXIN CD TEST
K925329 · LLH
Bd Becton Dickinson Vacutainer...
Microbiology · 154d
Cleared Mar 23, 1993
CODMAN GAAB NEUROENDOSCOPE
K923555 · GWB
Codman & Shurtleff, Inc.
Microbiology · 249d
Cleared Mar 23, 1993
TOXOPLASMA IGM IFA TEST SYSTEM
K924882 · GLZ
Zeus Scientific, Inc.
Microbiology · 176d
Cleared Mar 23, 1993
PYLORISCREEN
K925190 · LYR
New Horizons Diagnostics Co.
Microbiology · 160d
Cleared Mar 23, 1993
VITEK RAPID CALL-GRAM NEGATIV IDENT CARD
K925915 · LQM
Biomerieux Vitek, Inc.
Microbiology · 120d
Cleared Mar 18, 1993
APEX SPECIMEN BAG
K930313 · LIO
Apex Medical Technologies, Inc.
Microbiology · 55d
Cleared Mar 12, 1993
MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL
K922482 · LRG
Baxter Diagnostics, Inc.
Microbiology · 289d
Cleared Mar 11, 1993
API 20E/UNISCEPT 20E
K924814 · JSS
Analytical Products, Inc.
Microbiology · 167d
Cleared Mar 11, 1993
CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM
K926017 · JSS
Becton Dickinson Microbiology Systems
Microbiology · 101d
Cleared Mar 11, 1993
CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM
K926018 · JSS
Becton Dickinson Microbiology Systems
Microbiology · 101d
Cleared Mar 09, 1993
SENSITITRE SUSCEPTIBILITY PLATES
K923045 · JWY
Radiometer America, Inc.
Microbiology · 258d