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
1105–1128 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Dec 06, 1999
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
K993304 · DHR
Cogent Diagnotics , Ltd.
Immunology · 63d
Cleared Dec 01, 1999
ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56,...
K993388 · DHB
Pharmacia & Upjohn Co.
Immunology · 54d
Cleared Nov 30, 1999
K-ASSAY IGM
K993323 · CFF
Kamiya Biomedical Co.
Immunology · 57d
Cleared Nov 30, 1999
K-ASSAY TRANSFERRIN
K993537 · DDG
Kamiya Biomedical Co.
Immunology · 42d
Cleared Nov 30, 1999
TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3
K993546 · JJY
Medical Analysis Systems, Inc.
Immunology · 42d
Cleared Nov 30, 1999
ELECSYS PARATHYROID HORMONE CALCHECK
K993642 · JJX
Roche Diagnostics Corp.
Immunology · 33d
Cleared Nov 29, 1999
K-ASSAY C4
K993481 · DBI
Kamiya Biomedical Co.
Immunology · 46d
Cleared Nov 26, 1999
TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION
K981914 · JJX
The Binding Site, Ltd.
Immunology · 543d
Cleared Nov 26, 1999
MODIFICATION TO DOCUMENT THYROID CAL.VER
K993014 · JJY
Casco-Nerl Diagnostics Corporation...
Immunology · 79d
Cleared Nov 26, 1999
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
K993023 · JJY
Beckman Coulter, Inc.
Immunology · 78d
Cleared Nov 26, 1999
VARELISA RNP ANTIBODIES
K993589 · LKO
Pharmacia & Upjohn Co.
Immunology · 35d
Cleared Nov 24, 1999
IGA MININEPH ANTISERUM
K981786 · CFQ
The Binding Site, Ltd.
Immunology · 553d
Cleared Nov 24, 1999
AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
K992449 · MID
Cogent Diagnotics , Ltd.
Immunology · 125d
Cleared Nov 24, 1999
ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK
K992710 · JJY
Abbott Laboratories
Immunology · 105d
Cleared Nov 24, 1999
PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
K992900 · JJY
Roche Diagnostics Corp.
Immunology · 86d
Cleared Nov 24, 1999
PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
K993360 · JJY
Roche Diagnostics Corp.
Immunology · 49d
Cleared Nov 24, 1999
K-ASSAY C3
K993437 · CZW
Kamiya Biomedical Co.
Immunology · 43d
Cleared Nov 24, 1999
K-ASSAY ALPHA-1 AG
K993441 · LKL
Kamiya Biomedical Co.
Immunology · 43d
Cleared Nov 24, 1999
K-ASSAY ALPHA-1 AT
K993444 · DEM
Kamiya Biomedical Co.
Immunology · 43d
Cleared Nov 24, 1999
K-ASSAY HAPTOGLOBIN
K993480 · DAD
Kamiya Biomedical Co.
Immunology · 41d
Cleared Nov 23, 1999
K-ASSAY IGA
K993213 · CFF
Kamiya Biomedical Co.
Immunology · 60d
Cleared Nov 23, 1999
N LATEX FERRITIN
K993273 · DBF
Dade Behring, Inc.
Immunology · 54d
Cleared Nov 16, 1999
QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3
K993715 · JJT
Seracare Technology
Immunology · 13d
Cleared Nov 12, 1999
QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3
K992770 · JJY
Seracare Technology
Immunology · 87d