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
2257–2280 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 09, 1999
BIOTEST ANTI-EBV RECOMBINANT
K983839 · LSE
Biotest Diagnostics Corp.
Microbiology · 222d
Cleared Jun 09, 1999
BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG
K983841 · LSE
Biotest Diagnostics Corp.
Microbiology · 222d
Cleared Jun 09, 1999
BIOTEST ANTI-EBV RECOMBINANT, EA IGM
K983842 · LSE
Biotest Diagnostics Corp.
Microbiology · 222d
Cleared Jun 04, 1999
COPALIS MULTIPLEX EBV ANTIBODY ASSAY
K991660 · LSE
DiaSorin, Inc.
Microbiology · 21d
Cleared May 28, 1999
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974342 · LSL
Roche Molecular Systems, Inc.
Microbiology · 556d
Cleared May 26, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN...
K983805 · LFX
Zeus Scientific, Inc.
Microbiology · 210d
Cleared May 26, 1999
THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN...
K984120 · GQL
Zeus Scientific, Inc.
Microbiology · 189d
Cleared May 26, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN...
K984135 · GQL
Zeus Scientific, Inc.
Microbiology · 189d
Cleared May 14, 1999
COPALIS EBV-M ANTIBODY ASSAY
K991459 · LJN
DiaSorin, Inc.
Microbiology · 18d
Cleared May 10, 1999
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K983408 · JWY
Dade Microscan, Inc.
Microbiology · 224d
Cleared Apr 27, 1999
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K983711 · JWY
Dade Microscan, Inc.
Microbiology · 188d
Cleared Apr 22, 1999
ETEST FOR CEFUROXIME
K990722 · JWY
Ab Biodisk
Microbiology · 48d
Cleared Apr 15, 1999
QUANTA LITE LYME IGG ELISA
K984222 · LSR
Inova Diagnostics, Inc.
Microbiology · 141d
Cleared Apr 15, 1999
QUANTA LITE LYME IGM ELISA
K984234 · LSR
Inova Diagnostics, Inc.
Microbiology · 141d
Cleared Apr 02, 1999
TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K984513 · JTN
Oxoid , Ltd.
Microbiology · 105d
Cleared Mar 31, 1999
PRIMA SYSTEM - OLD, BARTELS ELISA - NEW
K990664 · LLH
Intracel Corp.
Microbiology · 30d
Cleared Mar 26, 1999
TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)
K990685 · JWY
Ab Biodisk
Microbiology · 23d
Cleared Mar 23, 1999
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
K984138 · LSR
Zeus Scientific, Inc.
Microbiology · 125d
Cleared Mar 22, 1999
ETEST MINOCYCLINE
K990297 · JWY
Ab Biodisk
Microbiology · 52d
Cleared Mar 18, 1999
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
K983336 · LKT
Diagnostic Products Corp.
Microbiology · 176d
Cleared Mar 18, 1999
HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
K983656 · LGC
Zeus Scientific, Inc.
Microbiology · 150d
Cleared Mar 15, 1999
ENTERO-TEST HP, MODEL #102-01
K983119 · LIO
Hdc Corp.
Microbiology · 188d
Cleared Mar 09, 1999
SYSTEM U3 FOR CEFUROXIME
K984491 · JWY
Ab Biodisk
Microbiology · 82d
Cleared Mar 09, 1999
SYSTEM U3 FOR CEPHALOTHIN
K984581 · JWY
Ab Biodisk
Microbiology · 76d