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
1561–1584 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 13, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML
K062207 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Sep 11, 2006
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062022 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 56d
Cleared Sep 08, 2006
QUICKVUE RSV (20 TEST KIT), MODEL 20193
K061008 · MCE
Quidel Corp.
Microbiology · 149d
Cleared Sep 08, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML
K062206 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Sep 01, 2006
MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML)
K062290 · LRG
Dade Behring, Inc.
Microbiology · 25d
Cleared Aug 31, 2006
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K062190 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 31d
Cleared Aug 30, 2006
IDI-VANR ASSAY
K061686 · NIJ
Geneohm Sciences Canada, Inc.
Microbiology · 76d
Cleared Aug 24, 2006
MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML)
K062293 · LRG
Dade Behring, Inc.
Microbiology · 17d
Cleared Aug 23, 2006
MICROSCAN MICROSTREP PLUS PANEL
K061872 · LRG
Dade Behring, Inc.
Microbiology · 51d
Cleared Aug 23, 2006
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 -...
K062179 · LRG
Dade Behring, Inc.
Microbiology · 23d
Cleared Aug 23, 2006
HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936
K062245 · JTN
Hardy Diagnostics
Microbiology · 21d
Cleared Aug 23, 2006
MICROSCAN MICROSTREP PLUS PANEL
K062276 · LRG
Dade Behring, Inc.
Microbiology · 16d
Cleared Aug 18, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP)...
K061869 · LON
Becton, Dickinson & CO
Microbiology · 46d
Cleared Aug 17, 2006
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY
K060652 · LSL
Gen-Probe, Inc.
Microbiology · 157d
Cleared Aug 10, 2006
ENZY-WELL SYPHILIS IGG, MODEL 91106
K050590 · LIP
Diesse Diagnostica Senese S.P.A.
Microbiology · 520d
Cleared Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K053287 · MKZ
Roche Diagnostics Corp.
Microbiology · 258d
Cleared Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K053289 · LSL
Roche Diagnostics Corp.
Microbiology · 258d
Cleared Aug 10, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML
K061867 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Aug 07, 2006
TREP-SURE TREPONEMAL ANTIBODY EIA
K053570 · LIP
Phoenix Biotech Corp.
Microbiology · 228d
Cleared Jul 31, 2006
DIASORIN LIAISON TREPONEMA ASSAY
K061247 · LIP
DiaSorin, Inc.
Microbiology · 89d
Cleared Jul 28, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP)...
K061673 · LON
Becton, Dickinson & CO
Microbiology · 44d
Cleared Jul 25, 2006
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088
K053446 · MKZ
Gen-Probe, Inc.
Microbiology · 225d
Cleared Jul 25, 2006
XPERT, GENEXPERT DX SYSTEM
K060540 · NJR
Cepheid
Microbiology · 146d
Cleared Jul 21, 2006
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061687 · JWY
Dade Behring, Inc.
Microbiology · 36d