Isolab, Inc. - FDA 510(k) Cleared Devices

Cleared Oct 18, 1996

ISOLAB'S T4 TEST KIT

K951014 · KLI

Chemistry · 592d

Cleared Feb 01, 1996

NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT

K950481 · JIA

Chemistry · 363d

Cleared Jan 26, 1996

PHENYLALANINE TEST KIT

K943547 · JNB

Chemistry · 554d

Cleared Sep 21, 1995

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

K950803 · JJT

Chemistry · 212d

Cleared Sep 05, 1995

FLUOROSCAN NEONATAL

K950415 · KHO

Chemistry · 217d

Cleared Nov 17, 1994

ISOSCAN

K944185 · JQT

Chemistry · 83d

Cleared Apr 26, 1994

RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT

K934013 · CIN

Chemistry · 251d

Cleared May 11, 1993

HEMOCARD CONTROL HB-AA, AE, FAA, FAE

K931234 · JCM

Chemistry · 62d

Cleared Jan 15, 1991

GLYC-AFFIN(TM)-GA

K905513 · LCP

Chemistry · 36d

Cleared Dec 26, 1990

GLYC-AFFIN GP

K904814 · LCP

Chemistry · 63d

Cleared Dec 07, 1990

LDL-DIRECT CONTROLS

K902740 · JJY

Chemistry · 168d

Cleared Mar 15, 1989

PG-NUMERIC(TM)

K883411 · JHF

Chemistry · 212d

Cleared Apr 05, 1988

GLYCO-PROBE GSP

K873428 · LCP

Chemistry · 224d

Cleared Nov 30, 1984

RESOLVE-CSF

K843122 · DFI

Chemistry · 114d

Cleared Mar 24, 1983

QUIK-SEP IGM ISOLATION SYSTEM

K830606 · DFT

Chemistry · 27d

Cleared Dec 03, 1982

GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY

K822867 · LCP

Chemistry · 67d

Cleared Sep 01, 1981

LIPO-SEP CHOLESTEROL AUDIT SYSTEM

K812318

Chemistry · 15d

Cleared May 29, 1981

ALPHA-THAL SCREEN TM CONTROL

K810976 · LGL

Chemistry · 49d

Cleared Apr 23, 1981

HEMOGLOBIN ELECTROPHORESIS CONTROL

K810919 · JBD

Chemistry · 17d

Cleared Dec 22, 1980

HDL-CHOLESTEROL CONTROL SERUM

K802997 · JJX

Chemistry · 27d

Cleared Apr 29, 1980

FAST HEMOGLOBIN CONTROL-LYOPHILIZED

K800794 · LCP

Chemistry · 20d

Cleared Oct 07, 1977

HEMOGLOBIN A2 TESTING SYSTEM

K771649 · JBD

Chemistry · 39d