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
1393–1416 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 02, 2009
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K090824 · MKZ
Becton, Dickinson & CO
Microbiology · 68d
Cleared May 28, 2009
IMMUNOCARD STAT CAMPY, MODEL 751530
K090700 · LQP
Meridian Bioscience, Inc.
Microbiology · 72d
Cleared May 27, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K090827 · LSL
Becton, Dickinson & CO
Microbiology · 62d
Cleared May 08, 2009
BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION...
K090409 · MXJ
Bio-Rad Laboratories
Microbiology · 79d
Cleared May 05, 2009
GBS PNA FISH
K082612 · OAH
Advandx, Inc.
Microbiology · 238d
Cleared May 05, 2009
ELECSYS RUBELLA IGG CALCHECK
K090311 · JJX
Roche Diagnostics
Microbiology · 88d
Cleared May 01, 2009
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
K083088 · OCC
Nanosphere, Inc.
Microbiology · 197d
Cleared Apr 16, 2009
PROGASTRO CD ASSAY
K090239 · LLH
Prodesse, Inc.
Microbiology · 73d
Cleared Apr 15, 2009
ORTHO T. CRUZI ELISA TEST SYSTEM
K072732 · MIU
Ortho-Clinical Diagnostics, Inc.
Microbiology · 567d
Cleared Apr 08, 2009
AVC A/H5N1 FLU TEST
K083278 · OMS
Arbor Vita Corportation
Microbiology · 152d
Cleared Apr 01, 2009
LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
K081527 · GQL
Millipore Corporation
Microbiology · 303d
Cleared Mar 26, 2009
EK/P. AERUGINOSA PNA FISH
K081433 · JSS
Advandx, Inc.
Microbiology · 309d
Cleared Mar 26, 2009
C. DIFF QUIK CHEK COMPLETE
K082499 · LLH
Techlab, Inc.
Microbiology · 209d
Cleared Mar 24, 2009
SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES
K083606 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 109d
Cleared Mar 16, 2009
VITEK 2 GRAM NEGATIVE DORIPENEM
K082346 · LON
bioMerieux, Inc.
Microbiology · 213d
Cleared Mar 06, 2009
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K081063 · NGZ
Trek Diagnostic Systems, Inc.
Microbiology · 326d
Cleared Mar 06, 2009
D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
K090073 · OMG
Diagnostic Hybrids, Inc.
Microbiology · 53d
Cleared Feb 23, 2009
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
K080008 · OMI
Bio-Rad Laboratories, Inc.
Microbiology · 418d
Cleared Feb 18, 2009
MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32...
K083262 · LTT
Siemens Healthcare Diagnostics
Microbiology · 105d
Cleared Feb 18, 2009
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
K083383 · LON
bioMerieux, Inc.
Microbiology · 93d
Cleared Feb 12, 2009
ELECSYS TOXO IGG CALCHECK
K083655 · JJX
Roche Diagnostics
Microbiology · 64d
Cleared Jan 30, 2009
PREMIER CAMPY, MODEL 618096
K083464 · LQP
Meridian Bioscience, Inc.
Microbiology · 67d
Cleared Jan 29, 2009
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML
K082852 · LON
Becton, Dickinson & CO
Microbiology · 122d
Cleared Jan 15, 2009
REAL-TIME PCR INTERNAL CONTROL 2B SET
K083430 · OLD
Nanogen, Inc.
Microbiology · 57d