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
1873–1896 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 27, 2003
FLU OIA A/B TEST KIT
K023556 · PSZ
Thermo Biostar, Inc.
Microbiology · 155d
Cleared Mar 27, 2003
QUANTA LITE H.PYLORI IGA ELISA
K024334 · LYR
Inova Diagnostics, Inc.
Microbiology · 91d
Cleared Mar 26, 2003
BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
K024240 · JSM
Bd
Microbiology · 93d
Cleared Mar 21, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML
K030579 · LON
Becton, Dickinson & CO
Microbiology · 25d
Cleared Mar 17, 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K024357 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 77d
Cleared Mar 06, 2003
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K024353 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 66d
Cleared Mar 05, 2003
IVD CRYPTO/GIARDIA DFA
K024113 · MHI
Ivd Research, Inc.
Microbiology · 82d
Cleared Feb 28, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML
K030091 · LON
Bd Diagnostic Systems
Microbiology · 49d
Cleared Feb 20, 2003
XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
K020595 · JWZ
Xenotope Diagnostics, Inc.
Microbiology · 363d
Cleared Feb 10, 2003
ACON STREP A TWIST TEST DEVICE
K023766 · GTY
Acon Laboratories Co.
Microbiology · 90d
Cleared Feb 10, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML
K024153 · LON
Becton, Dickinson & CO
Microbiology · 55d
Cleared Jan 31, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML
K024152 · LON
Becton, Dickinson & CO
Microbiology · 45d
Cleared Jan 29, 2003
SAS RSV TEST
K022845 · GQG
Sa Scientific, Inc.
Microbiology · 155d
Cleared Jan 29, 2003
OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)
K023677 · LIB
Osmetech
Microbiology · 89d
Cleared Jan 24, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K023568 · LON
Becton, Dickinson & CO
Microbiology · 92d
Cleared Jan 17, 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K030067 · MJX
Ortho-Clinical Diagnostics
Microbiology · 10d
Cleared Jan 14, 2003
RSV OIA
K023779 · GQG
Thermo Biostar, Inc.
Microbiology · 63d
Cleared Jan 08, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN
K023895 · LON
Becton, Dickinson & CO
Microbiology · 47d
Cleared Jan 03, 2003
IMMUNOCARD STAT! E. COLI O157 PLUS
K023599 · GMZ
Meridian Bioscience, Inc.
Microbiology · 67d
Cleared Dec 24, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML)
K023634 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Dec 23, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML
K023527 · LON
Becton, Dickinson & CO
Microbiology · 63d
Cleared Dec 20, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K023858 · LON
Becton, Dickinson & CO
Microbiology · 30d
Cleared Dec 18, 2002
DFA RESPIRATORY VIRUS SCREENING & ID KIT
K022713 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 126d
Cleared Dec 16, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN...
K023361 · LON
Dade Behring, Inc.
Microbiology · 70d