Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
1585–1608 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 19, 2006
MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN
K062585 · LRG
Dade Behring, Inc.
Microbiology · 18d
Cleared Sep 19, 2006
MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID
K062596 · LRG
Dade Behring, Inc.
Microbiology · 18d
Cleared Sep 15, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND...
K060770 · LOL
Ortho-Clinical Diagnostics, Inc.
Microbiology · 177d
Cleared Sep 14, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS
K060678 · LOL
Ortho-Clinical Diagnostics, Inc.
Microbiology · 184d
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