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510(k) K951329

IMMUCHEM GAL-MW EA by Icn Pharmaceuticals, Inc. — Product Code JIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1995
Date Received
March 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Methods, Galactose
Device Class
Class I
Regulation Number
862.1310
Review Panel
CH
Submission Type

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  • K770458 — BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. (May 10, 1977)
  • K770449 — CALCIUM PROCEDURE, TEKPOINT DIRECT (May 3, 1977)

Other clearances for product code JIA

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  • K133652 — GSP NEONATAL TOTAL GALACTOSE KIT (April 28, 2014)
  • K121101 — SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT (June 20, 2013)
  • K071649 — NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND (August 7, 2008)
  • K990644 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY (June 21, 1999)
  • K990654 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT (June 21, 1999)
  • K991498 — ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL (June 16, 1999)
  • K950481 — NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT (February 1, 1996)