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: Immunology ×
3,794 results
1777–1800 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 20, 1995
N LATEX IGA
K952309 · CZP
Behring Diagnostics, Inc.
Immunology · 34d
Cleared Jun 07, 1995
HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY
K945748 · DHB
Hycor Biomedical, Inc.
Immunology · 196d
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