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
1681–1704 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 11, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML
K051272 · LON
Becton, Dickinson & CO
Microbiology · 55d
Cleared Jul 07, 2005
BD DIRECTIGEN EZ FLU A + B
K042472 · PSZ
Becton, Dickinson & CO
Microbiology · 300d
Cleared Jul 05, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML
K051266 · LON
Becton, Dickinson & CO
Microbiology · 50d
Cleared Jun 24, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML
K051204 · LON
Becton, Dickinson & CO
Microbiology · 44d
Cleared Jun 23, 2005
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K051202 · JWY
Dade Behring, Inc.
Microbiology · 43d
Cleared Jun 21, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML
K051183 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Jun 15, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML
K051109 · LON
Becton, Dickinson & CO
Microbiology · 44d
Cleared Jun 03, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML
K051138 · LON
Becton, Dickinson & CO
Microbiology · 30d
Cleared Jun 01, 2005
DIASORIN LIAISON CMV IGM/IGG
K040290 · LFZ
Diasorin S.P.A
Microbiology · 481d
Cleared May 27, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML
K050946 · LON
Becton, Dickinson & CO
Microbiology · 42d
Cleared May 24, 2005
BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML)
K050982 · LON
Becton, Dickinson & CO
Microbiology · 35d
Cleared May 23, 2005
VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
K050976 · LON
bioMerieux, Inc.
Microbiology · 35d
Cleared May 20, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE...
K050865 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared May 12, 2005
BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML
K050780 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared May 12, 2005
VITEK 2 GRAM POSITIVE MEROPENEM
K050816 · LON
bioMerieux, Inc.
Microbiology · 42d
Cleared May 12, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16...
K050881 · LON
Becton, Dickinson & CO
Microbiology · 35d
Cleared Apr 29, 2005
DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
K040120 · LLM
DiaSorin, Inc.
Microbiology · 465d
Cleared Apr 29, 2005
ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
K042118 · JRY
Zeus Scientific, Inc.
Microbiology · 266d
Cleared Apr 29, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML
K050745 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Apr 29, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML
K050747 · LON
Becton, Dickinson & CO
Microbiology · 38d
Cleared Apr 14, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML
K050555 · LON
Becton, Dickinson & CO
Microbiology · 42d
Cleared Apr 12, 2005
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
K042092 · LJN
Zeus Scientific, Inc.
Microbiology · 252d
Cleared Mar 29, 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN
K050043 · LRG
Dade Behring, Inc.
Microbiology · 78d
Cleared Mar 22, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML
K050400 · LON
Becton, Dickinson & CO
Microbiology · 34d