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

44 results for "Isolab, Inc."

25–44 of 44

Search insights Median review: 83d Cleared: 100% Top manufacturer: Isolab, Inc. Lead specialty: Chemistry

Cleared Aug 26, 1986

VISIBLE-CHLAMYDIA(TM) TEST SYSTEM

Microbiology · 47d

Cleared May 20, 1986

VISIBLE-HERPES TM TEST SYSTEM

Microbiology · 179d

Cleared Nov 30, 1984

Chemistry · 114d

Cleared Sep 09, 1984

SICKLING HEMOGLOBIN CONTROLS, NORMAL

Hematology · 102d

Cleared Apr 04, 1984

SICKLE HB ASSAY

Hematology · 16d

Cleared Feb 04, 1984

Hematology · 31d

Cleared Mar 24, 1983

QUIK-SEP IGM ISOLATION SYSTEM

Chemistry · 27d

Cleared Dec 03, 1982

GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY

Chemistry · 67d

Cleared Jun 25, 1982

QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL

Hematology · 109d

Cleared Sep 01, 1981

LIPO-SEP CHOLESTEROL AUDIT SYSTEM

Chemistry · 15d

Cleared May 29, 1981

ALPHA-THAL SCREEN TM CONTROL

Chemistry · 49d

Cleared Apr 23, 1981

HEMOGLOBIN ELECTROPHORESIS CONTROL

Chemistry · 17d

Cleared Jan 16, 1981

ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT

Hematology · 172d

Cleared Dec 22, 1980

HDL-CHOLESTEROL CONTROL SERUM

Chemistry · 27d

Cleared Jul 21, 1980

HEMOHLOBIN A2 CONTROL-LYOPHILIZED

Hematology · 35d

Cleared Apr 29, 1980

FAST HEMOGLOBIN CONTROL-LYOPHILIZED

Chemistry · 20d

Cleared Jul 17, 1979

SICKLE-CELL F TEST

Hematology · 29d

Cleared Nov 07, 1978

HEMOGLOBIN, TESTING SYSTEM

Hematology · 4d

Cleared Jul 27, 1978

General & Plastic Surgery · 43d

Cleared Oct 07, 1977

HEMOGLOBIN A2 TESTING SYSTEM

Chemistry · 39d