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
1609–1632 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
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