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
1777–1800 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 05, 1995
HEMAGEN ENA SCREENING KIT (EIA METHOD)
K952076 · LLL
Hemagen Diagnostics, Inc.
Immunology · 33d
Cleared Jun 05, 1995
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
K952077 · LLL
Hemagen Diagnostics, Inc.
Immunology · 33d
Cleared Jun 05, 1995
OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT
K952466 · JHN
Olympus America, Inc.
Immunology · 10d
Cleared Jun 01, 1995
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM
K950802 · JJY
International Enzymes, Inc.
Immunology · 100d
Cleared Jun 01, 1995
HEP-2000 COLORZYME ANA-RO TEST SYSTEM
K950979 · DHN
Immuno Concepts, Inc.
Immunology · 90d
Cleared Jun 01, 1995
HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT
K951966 · JZJ
Kent Laboratories, Inc.
Immunology · 35d
Cleared May 30, 1995
HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT
K951967 · DBA
Kent Laboratories, Inc.
Immunology · 33d
Cleared May 30, 1995
HUMAN C1Q RADIAL IMMUNODIFFUSION KIT
K951968 · DAK
Kent Laboratories, Inc.
Immunology · 33d
Cleared May 23, 1995
PROSTAT CONTROL
K943394 · JJY
Quantimetrix Corp.
Immunology · 313d
Cleared May 23, 1995
ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND...
K950629 · DHB
Bio-Rad Laboratories, Inc.
Immunology · 99d
Cleared May 16, 1995
LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3
K945651 · JJY
Bio-Rad
Immunology · 180d
Cleared May 15, 1995
IL TEST BETA-2MICROGLOBULIN
K943686 · JZG
Instrumentation Laboratory CO
Immunology · 290d
Cleared May 15, 1995
MARDX ENA EIA TEST SYSTEM
K946218 · LJM
Hogan & Hartson
Immunology · 145d
Cleared May 15, 1995
MARDX MITOCHONDRIA EIA TEST SYSTEM
K950110 · LJM
Hogan & Hartson
Immunology · 124d
Cleared May 15, 1995
BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN...
K951635 · DEW
Beckman Instruments, Inc.
Immunology · 38d
Cleared Apr 24, 1995
ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY)
K950217 · JZO
American Laboratory Products Co., Ltd.
Immunology · 95d
Cleared Apr 24, 1995
LEUKO-TEST
K951101 · DEG
Techlab, Inc.
Immunology · 45d
Cleared Apr 21, 1995
ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)
K950088 · JZO
American Laboratory Products Co., Ltd.
Immunology · 101d
Cleared Apr 21, 1995
ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY)
K950089 · JZO
American Laboratory Products Co., Ltd.
Immunology · 101d
Cleared Apr 21, 1995
ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY)
K950090 · JZO
American Laboratory Products Co., Ltd.
Immunology · 101d
Cleared Apr 20, 1995
DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY
K931192 · DEH
Dako Corp.
Immunology · 772d
Cleared Apr 20, 1995
MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2
K951057 · DCK
Medical Analysis Systems, Inc.
Immunology · 44d
Cleared Apr 17, 1995
AUTOSTAT II ANTI-TPO
K943580 · JNL
Cogent Diagnotics , Ltd.
Immunology · 269d
Cleared Apr 17, 1995
VARELISA COMBINED DNA ANTIBODIES EIA
K944334 · LRM
Elias U.S.A., Inc.
Immunology · 223d