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."

1–24 of 44

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

Cleared Oct 18, 1996

ISOLAB'S T4 TEST KIT

Chemistry · 592d

Cleared Feb 01, 1996

NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT

Chemistry · 363d

Cleared Jan 26, 1996

PHENYLALANINE TEST KIT

Chemistry · 554d

Cleared Sep 21, 1995

ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE

Chemistry · 212d

Cleared Sep 05, 1995

FLUOROSCAN NEONATAL

Chemistry · 217d

Cleared Jan 20, 1995

QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY

Hematology · 255d

Cleared Jan 20, 1995

QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS

Hematology · 259d

Cleared Nov 17, 1994

Chemistry · 83d

Cleared Apr 26, 1994

RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT

Chemistry · 251d

Cleared Jan 27, 1994

HEMOCARD, HEMOGLOBIN C ASSAY

Hematology · 577d

Cleared May 11, 1993

HEMOCARD CONTROL HB-AA, AE, FAA, FAE

Chemistry · 62d

Cleared Apr 08, 1993

HEMOCARD HEMOGLOBIN E

Hematology · 92d

Cleared Dec 01, 1992

HEMOCARD(TM) CONTROL

Hematology · 104d

Cleared Nov 17, 1992

CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL

Hematology · 223d

Cleared Oct 09, 1991

HEMOCARD HEMOGLOBIN S

Hematology · 159d

Cleared Apr 15, 1991

Hematology · 73d

Cleared Mar 11, 1991

HEMOCARD CONTROL

Hematology · 38d

Cleared Jan 15, 1991

GLYC-AFFIN(TM)-GA

Chemistry · 36d

Cleared Dec 26, 1990

Chemistry · 63d

Cleared Dec 07, 1990

LDL-DIRECT CONTROLS

Chemistry · 168d

Cleared Apr 12, 1990

QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD

Immunology · 16d

Cleared Mar 15, 1989

Chemistry · 212d

Cleared Nov 22, 1988

GHB SAMPLE PAPER

Hematology · 277d

Cleared Apr 05, 1988

GLYCO-PROBE GSP

Chemistry · 224d