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

149 results for "American Dade"

1–24 of 149

Search insights Median review: 42d Cleared: 100% Top manufacturer: American Dade Lead specialty: Chemistry

Cleared Oct 20, 1987

STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY

Chemistry · 77d

Cleared Sep 29, 1987

STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

Chemistry · 49d

Cleared Sep 14, 1987

STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY

Chemistry · 41d

Cleared Sep 02, 1987

PARAMAX URINE/CSF CALIBRATOR

Chemistry · 50d

Cleared Aug 06, 1987

DATA-FI DIMERTEST LATEX ASSAY

Hematology · 59d

Cleared Jul 31, 1987

AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

Chemistry · 53d

Cleared Jul 21, 1987

STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY

Immunology · 61d

Cleared Jul 09, 1987

DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR

Chemistry · 48d

Cleared Jul 07, 1987

PARAMAX CHOLESTEROL REAGENT

Chemistry · 40d

Cleared Jul 06, 1987

DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET

Hematology · 18d

Cleared Mar 19, 1987

STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.

Chemistry · 65d

Cleared Feb 25, 1987

Chemistry · 22d

Cleared Feb 10, 1987

IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)

Hematology · 12d

Cleared Feb 10, 1987

IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)

Hematology · 12d

Cleared Nov 13, 1986

THROMBOPLASTIN.R

Hematology · 15d

Cleared Nov 13, 1986

THROMBOPLASTIN.C

Hematology · 15d

Cleared Nov 13, 1986

THROMBOPLASTIN.FS

Hematology · 15d

Cleared Nov 05, 1986

SMI MULTIPETTOR(TM)

Chemistry · 30d

Cleared Oct 17, 1986

ACTIN FSL ACTIVATED PTT REAGENT

Hematology · 32d

Cleared Sep 29, 1986

PARAMAX ELECTROLYTE CALIBRATOR

Chemistry · 20d

Cleared Aug 19, 1986

STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY

Chemistry · 26d

Cleared Aug 19, 1986

STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY

Chemistry · 54d

Cleared Aug 04, 1986

PARAMAX LIPASE REAGENT

Chemistry · 39d

Cleared Jun 16, 1986

STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY

Toxicology · 17d