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
1753–1776 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 30, 2004
WEST NILE VIRUS IGM CAPTURE ELISA
K040854 · NOP
Focus Technologies, Inc.
Microbiology · 90d
Cleared Jun 08, 2004
VITEK 2 ESBL TEST
K040845 · LON
bioMerieux, Inc.
Microbiology · 68d
Cleared Jun 07, 2004
PASCO MIC AND MIC/ID PANELS
K041214 · JWY
Pasco Laboratories, Inc.
Microbiology · 28d
Cleared Jun 03, 2004
QUICKELISA ANTHRAX-PA KIT
K040407 · NRL
Immunetics, Inc.
Microbiology · 107d
Cleared May 28, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST
K033458 · LON
Becton, Dickinson & CO
Microbiology · 211d
Cleared May 27, 2004
C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL
K032897 · LLH
Ivd Research, Inc.
Microbiology · 253d
Not Cleared May 21, 2004
GLUCATELL
DEN040003 · NQZ
Associates of Cape Cod, Inc.
Microbiology · 60d
Cleared May 19, 2004
LIQUICHEK TORCH PLUS IGM CONTROL
K040822 · JJY
Bio-Rad Laboratories, Inc.
Microbiology · 50d
Cleared May 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML
K040716 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Apr 26, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040846 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 25d
Cleared Apr 09, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE
K033362 · LON
Becton, Dickinson & CO
Microbiology · 171d
Cleared Apr 09, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE...
K033907 · LON
Becton, Dickinson & CO
Microbiology · 114d
Cleared Apr 07, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040619 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 29d
Cleared Apr 02, 2004
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN...
K031601 · LON
Dade Behring, Inc.
Microbiology · 317d
Cleared Apr 02, 2004
GENZYME OSOM TRICHOMONAS RAPID TEST
K033864 · JWZ
Genzyme Corp.
Microbiology · 112d
Cleared Mar 19, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K040099 · LON
Becton, Dickinson & CO
Microbiology · 59d
Cleared Mar 18, 2004
IDI-MRSA
K033415 · NQX
Infectio Diagnostic (I.D.I.), Inc.
Microbiology · 143d
Cleared Mar 11, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE
K040106 · LON
Becton, Dickinson & CO
Microbiology · 51d
Cleared Mar 09, 2004
BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY
K033861 · LQH
Becton, Dickinson & CO
Microbiology · 88d
Cleared Mar 02, 2004
CT OIA
K032330 · LJC
Thermo Biostar, Inc.
Microbiology · 217d
Cleared Mar 01, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML
K032675 · LON
Becton, Dickinson & CO
Microbiology · 185d
Cleared Mar 01, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
K033948 · LRG
Dade Behring, Inc.
Microbiology · 73d
Cleared Feb 27, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE
K040006 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Feb 26, 2004
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
K033479 · LLH
Remel, Inc.
Microbiology · 115d