Medical Device Manufacturer · US , Mchenry , IL

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

44 submissions · 44 cleared · Since 1977

Total

Cleared

Denied

Isolab, Inc. has 44 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 44 cleared submissions from 1977 to 1996. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Isolab, Inc. Filter by specialty or product code using the sidebar.

Isolab, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Isolab, Inc.

44 devices

1-12 of 44

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

QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS

K942222 · JCM

Hematology · 259d

Cleared Jan 20, 1995

QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY

RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT

K934013 · CIN

Chemistry · 251d

Cleared Jan 27, 1994

HEMOCARD, HEMOGLOBIN C ASSAY

K923153 · MLL

Hematology · 577d

Cleared May 11, 1993

HEMOCARD CONTROL HB-AA, AE, FAA, FAE

K931234 · JCM

Chemistry · 62d

Cleared Apr 08, 1993

HEMOCARD HEMOGLOBIN E

K930070 · CKA

Hematology · 92d

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

FDA 510(k) Regulatory Record - Isolab, Inc.

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