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: Immunology ×
3,792 results
3217–3240 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 02, 1982
PREG/TEX PREGNANCY TEST
K821387 · JHJ
Texas Immunology, Inc.
Immunology · 23d
Cleared May 28, 1982
SERO/TEX LE TEST
K821385 · DHC
Texas Immunology, Inc.
Immunology · 18d
Cleared May 28, 1982
EMIT C-REACTIVE PROTEIN ASSAY
K821413 · DCN
Syva Co.
Immunology · 16d
Cleared May 21, 1982
SERO/TEX RF TEST
K821319 · DHR
Texas Immunology, Inc.
Immunology · 17d
Cleared May 13, 1982
ENDAB T4 ENZYME IMMUNOASSAY KIT
K821141 · CDX
Immunotech Corp.
Immunology · 22d
Cleared May 07, 1982
IP SPECIFIC E
K821094 · DGO
Diagnostic Reagent Tech.
Immunology · 18d
Cleared May 05, 1982
VENTRE/SPEC IGE CONTROLS
K820897 · DGC
Ventrex Laboratories, Inc.
Immunology · 36d
Cleared May 05, 1982
SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA
K821097
Icl Scientific
Immunology · 15d
Cleared Apr 29, 1982
ANTIHUMAN IGG GLOBULIN FITC LABELED
K821018 · DEW
Microbiological Research Corp.
Immunology · 17d
Cleared Apr 21, 1982
VENTREX 125I ANTI-IGE ALLERGY ISOTOPE
K820896 · DGC
Ventrex Laboratories, Inc.
Immunology · 22d
Cleared Apr 08, 1982
CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV
K820298 · DHX
Ventrex Laboratories, Inc.
Immunology · 63d
Cleared Apr 06, 1982
KALLESTAD RAST REAGENTS
K820029 · DHB
Kallestad Laboratories, Inc.
Immunology · 91d
Cleared Mar 04, 1982
ENZYGNOST TM RUBELLA IGM
K813493 · LFX
Calbiochem-Behring Corp.
Immunology · 80d
Cleared Feb 12, 1982
ANA TEST (MOUSE LIVER SUBSTRATE)
K820265 · DHN
Meloy Laboratories, Inc.
Immunology · 10d
Cleared Feb 10, 1982
FREEZE DRIED FICIN
K813404 · KSK
Biological Corp. of America
Immunology · 65d
Cleared Jan 28, 1982
PIPERACILLIN 100 MCG. SENSITIVITY DISCS
K812524 · JTN
Difco Laboratories, Inc.
Immunology · 148d
Cleared Jan 26, 1982
AFT SYSTEM PROFICIENCY TESTING PROGRAM
K820088 · DBL
Calbiochem-Behring Corp.
Immunology · 13d
Cleared Jan 22, 1982
TOTAL HEMOLYTIC COMPLEMENT TEST KIT
K820005
Meloy Laboratories, Inc.
Immunology · 18d
Cleared Jan 18, 1982
QUANTAFLUOR FLUORESCENT TEST REAGENTS
K813592 · DHN
Kallestad Laboratories, Inc.
Immunology · 21d
Cleared Dec 31, 1981
PHADEBAS/PHADEZYM IGE REAGENTS
K813189 · DGC
Pharmacia, Inc.
Immunology · 45d
Cleared Dec 17, 1981
FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN
K812298 · GHH
Syn-Kit, Inc.
Immunology · 125d
Cleared Dec 17, 1981
NEIA TRANSFERRIN ENZYMEIMMUNOASSAY
K813288 · DDG
New England Immunology Assoc.
Immunology · 24d
Cleared Dec 17, 1981
RA-80 POSITIVE CONTROL
K813309 · DHR
Sun-Kit
Immunology · 23d
Cleared Dec 02, 1981
QUANTIMETRIC 2 TEST KIT
K813242 · KEW
Kallestad Laboratories, Inc.
Immunology · 15d