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