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
1585–1608 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 18, 2006
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061536 · JWY
Dade Behring, Inc.
Microbiology · 46d
Cleared Jul 03, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN)...
K061327 · LON
Becton, Dickinson & CO
Microbiology · 52d
Cleared Jun 23, 2006
COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM
K061301 · JTW
Copan Diagnostics, Inc.
Microbiology · 44d
Cleared Jun 20, 2006
VITEK 2 GRAM POSITIVE VRSA SCREEN
K061347 · LON
bioMerieux, Inc.
Microbiology · 36d
Cleared Jun 12, 2006
OSOM INFLUENZA A&B TEST
K061508 · PSZ
Genzyme Corp.
Microbiology · 11d
Cleared Jun 07, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML
K061355 · LON
Becton, Dickinson & CO
Microbiology · 23d
Cleared Jun 02, 2006
PLATELIA ASPERGILLUS EIA, MODEL 62793
K060641 · NOM
Bio-Rad
Microbiology · 84d
Cleared May 25, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT...
K060324 · LON
Becton, Dickinson & CO
Microbiology · 105d
Cleared May 16, 2006
SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL
K060783 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 55d
Cleared May 12, 2006
PARA-PRO FC50
K053257 · LKS
Alpha-Tec Systems, Inc.
Microbiology · 171d
Cleared May 11, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML
K060558 · LON
Becton, Dickinson & CO
Microbiology · 70d
Cleared May 08, 2006
S. AUREUS PNA FISH
K060099 · NXX
Advandx, Inc.
Microbiology · 115d
Cleared May 01, 2006
PYLO-PLUS
K052708 · LYR
Arj Medical, Inc.
Microbiology · 214d
Cleared Apr 26, 2006
C. DIFF QUIK CHEK
K053572 · MCB
Techlab, Inc.
Microbiology · 125d
Cleared Apr 26, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML,...
K060447 · LON
Becton, Dickinson & CO
Microbiology · 64d
Cleared Apr 21, 2006
SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE....
K060621 · JWY
Tds Holdings, Inc.
Microbiology · 44d
Cleared Apr 14, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML
K060257 · LON
Becton, Dickinson & CO
Microbiology · 72d
Cleared Apr 12, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND...
K060217 · LON
Becton, Dickinson & CO
Microbiology · 75d
Cleared Apr 12, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN),...
K060444 · LON
Becton, Dickinson & CO
Microbiology · 50d
Cleared Mar 29, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA.
K060493 · LON
Becton, Dickinson & CO
Microbiology · 33d
Cleared Mar 23, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN...
K060312 · LON
Dade Behring, Inc.
Microbiology · 43d
Cleared Mar 17, 2006
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND...
K060218 · LON
Becton, Dickinson & CO
Microbiology · 49d
Cleared Mar 17, 2006
TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K060286 · JTN
Oxoid , Ltd.
Microbiology · 42d
Cleared Mar 10, 2006
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
K053335 · LYR
Meridian Bioscience, Inc.
Microbiology · 99d