FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
3121–3144 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 26, 1994
EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY
K931520 · LJN
Mrl Diagnostics
Microbiology · 396d
Cleared Apr 26, 1994
CLOSTRIDIUM DIFFICILE TOX-B TEST
K935296 · LLH
Techlab, Inc.
Microbiology · 174d
Cleared Apr 21, 1994
OT IGG SORBENT
K934324 · DEW
Organon Teknika Corp.
Microbiology · 230d
Cleared Apr 21, 1994
SPECIMEN TRANSPORT MEDIUM
K935618 · JSM
Biowhittaker Molecular Applications,...
Microbiology · 150d
Cleared Apr 21, 1994
QTEST(R) STREP
K935667 · GTY
Becton Dickinson Advanced Diagnostics
Microbiology · 146d
Cleared Apr 21, 1994
SERIM PYLORITEK REAGENT STRIPS
K936034 · JTO
Serim Research Corp.
Microbiology · 127d
Cleared Apr 20, 1994
RIM E.COLI 0157:H7 LATEX TEST
K933457 · GNA
Remel Co.
Microbiology · 280d
Cleared Apr 20, 1994
UNKNOWN
K934774 · LSE
Granbio, Inc.
Microbiology · 197d
Cleared Apr 06, 1994
PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY
K920302 · LSK
Gen-Probe, Inc.
Microbiology · 806d
Cleared Mar 30, 1994
DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT
K931922 · JSM
Viratest Intl., Inc.
Microbiology · 348d
Cleared Mar 30, 1994
THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS...
K934539 · GKL
Intl. Remote Imaging Systems
Microbiology · 194d
Cleared Mar 29, 1994
SENSI-CAL AMCO AEPA-1
K935566 · LIE
Radiometer America, Inc.
Microbiology · 131d
Cleared Mar 25, 1994
PATHODX CYTOMEGALOVIRUS
K934798 · LIN
Diagnostic Products Corp.
Microbiology · 169d
Cleared Mar 11, 1994
GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST
K924715 · MDK
Gen-Probe, Inc.
Microbiology · 536d
Cleared Mar 11, 1994
FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST
K931557 · GRZ
Fuller Laboratories, Inc.
Microbiology · 346d
Cleared Mar 07, 1994
OPUS(R) SEROLOGY CONTROLS, MODIFICATION
K934137 · MJX
Pb Diagnostic Systems, Inc.
Microbiology · 194d
Cleared Mar 01, 1994
BIOMIC VIDEO PLATE READER
K932122 · KZK
Giles Scientific, Inc.
Microbiology · 302d
Cleared Mar 01, 1994
PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISC
K940359 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 25d
Cleared Feb 25, 1994
BACTICARD CANDIDA
K935124 · JXB
Remel Co.
Microbiology · 120d
Cleared Feb 23, 1994
BACTICARD E. COLI
K934986 · JTO
Remel Co.
Microbiology · 127d
Cleared Feb 22, 1994
CULTURESWAB TRANSPORT SYSTEM
K934894 · JTW
Difco Laboratories, Inc.
Microbiology · 140d
Cleared Feb 17, 1994
CRYPTO-LEX SYSTEM
K930418 · GMD
Trinity Laboratories, Inc.
Microbiology · 387d
Cleared Feb 17, 1994
STOOL TRANSPORT/PROCESSOR
K933370 · LKS
Sage Products, Inc.
Microbiology · 223d
Cleared Feb 17, 1994
PARASAFE(R) FIXATIVE
K935316 · LKS
Scientific Device Laboratory, Inc.
Microbiology · 107d