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
2089–2112 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 29, 2000
MODIFICATION TO: PRONTO DRY
K002451 · LYR
Medical Instruments Corporation, AG
Microbiology · 51d
Cleared Sep 05, 2000
LINEZOLID, 30UG, BBL SENSI-DISC
K002165 · JTN
Dickinson, and Co.
Microbiology · 49d
Cleared Aug 31, 2000
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS...
K002453 · LGD
Beckman Coulter, Inc.
Microbiology · 21d
Cleared Aug 24, 2000
CHROMOSTREAK
K000718 · JSN
Novamed , Ltd.
Microbiology · 174d
Cleared Aug 21, 2000
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
K001875 · LFX
Diamedix Corp.
Microbiology · 62d
Cleared Aug 10, 2000
PASCO MIC AND MIC/ID PANELS
K001953 · JWY
Pasco Laboratories, Inc.
Microbiology · 44d
Cleared Aug 09, 2000
MODIFICATION TO PASCO MIC AND MIC/ID PANELS
K001887 · JWY
Pasco Laboratories, Inc.
Microbiology · 49d
Cleared Aug 07, 2000
ETEST ESBL CT/CTL STRIP
K001547 · JWY
Ab Biodisk
Microbiology · 81d
Cleared Aug 07, 2000
DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
K001767 · LJO
Diamedix Corp.
Microbiology · 56d
Cleared Aug 04, 2000
PASCO MIC AND MIC/ID PANELS
K001721 · LTT
Pasco Laboratories, Inc.
Microbiology · 59d
Cleared Jul 27, 2000
HARDY DISK CLARITHROMYCIN, 15MCG
K001728 · JTN
Hardy Diagnostics
Microbiology · 50d
Cleared Jul 24, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)
K001558 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 66d
Cleared Jul 18, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K001573 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 57d
Cleared Jul 18, 2000
PASCO MIC AND MIC/ID PANELS
K001612 · JWY
Pasco Laboratories, Inc.
Microbiology · 54d
Cleared Jul 12, 2000
PASCO MIC AND MIC/ID PANELS
K001516 · JWY
Pasco Laboratories, Inc.
Microbiology · 57d
Cleared Jul 07, 2000
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
K001707 · LGD
Diamedix Corp.
Microbiology · 32d
Cleared Jun 28, 2000
BD DIRECTIGEN FLU A+B
K001364 · PSZ
Bd Becton Dickinson Vacutainer...
Microbiology · 58d
Cleared Jun 12, 2000
THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
K000687 · GMQ
Beacon Biologicals, Inc.
Microbiology · 104d
Cleared Jun 07, 2000
HARDYDISK CINOXACIN, 100 MCG
K001487 · JTN
Hardy Diagnostics
Microbiology · 26d
Cleared Jun 06, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)
K001036 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 67d
Cleared Jun 01, 2000
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
K000463 · LYR
Diagnostic Products Corp.
Microbiology · 111d
Cleared Jun 01, 2000
HARDYDISK CEFOPERAZONE, 75 MCG
K001489 · JTN
Hardy Diagnostics
Microbiology · 20d
Cleared Jun 01, 2000
HARDYDISK CEFONICID, 30 MCG
K001490 · JTN
Hardy Diagnostics
Microbiology · 20d
Cleared May 23, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)
K001035 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 53d