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
1105–1128 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Nov 12, 1999
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG
K992790 · JZO
Brahms Diagnostica, LLC
Immunology · 85d
Cleared Nov 12, 1999
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
K992791 · JZO
Brahms Diagnostica, LLC
Immunology · 85d