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510(k) K771001

STATZYME GLUCOSE by Worthington Biochemical Corp. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1977
Date Received
June 3, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Worthington Biochemical Corp.

  • K780389 — HDL REAGENT SET FOR LIPOPROTEINS (April 19, 1978)
  • K780096 — LDH ISOENZYME CONTROL SERUM (March 3, 1978)
  • K772356 — LDH ISOENZYME COLUMN REAGENT SET (January 24, 1978)
  • K772025 — URIC ACID STD. FOR QUANT. URIC ACID (November 11, 1977)
  • K770831 — STATZYME URIC ACID REAGENT (July 11, 1977)
  • K771143 — INORGANIC PHOSPHORUS STANDARDS (July 11, 1977)
  • K770470 — WORTHINGTON BUN (June 2, 1977)
  • K770277 — CHOLESTEROL STANDARDS (March 1, 1977)
  • K761262 — TRIGLYCERIDES (LIPASE) REAGENT SET (December 29, 1976)
  • K761263 — CHOLESTEROL AUTOMATED REAGENT (December 29, 1976)

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