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510(k) K905227

GLUCOSE (HK) REAGENT, UNIVERSAL by Enzyme Technology, Inc. — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1991
Date Received
November 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Enzyme Technology, Inc.

  • K912027 — CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL (January 30, 1992)
  • K912028 — URIC ACID (URICASE) REAGENT, UNIVERSAL (December 18, 1991)
  • K905226 — TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL (December 11, 1990)
  • K896073 — CHOLESTEROL, UNIVERSAL ET (December 12, 1989)

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