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510(k) K943503

CHEMCARD GLUCOSE TEST by Chem-Elec, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1996
Date Received
July 20, 1994
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 Chem-Elec, Inc.

  • K864159 — SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD (June 10, 1988)
  • K811319 — CHLORIDE REAGENT KIT (August 13, 1981)
  • K811381 — ASTRA (August 13, 1981)
  • K811165 — GLUCOSE OXIDASE RATE REAGENT (August 13, 1981)
  • K811406 — CREATININE RATE REAGENT KIT (August 13, 1981)
  • K811310 — SODIUM/POTASSIUM REAGENT KITS (July 10, 1981)
  • K811193 — BUN RATE REAGENT (July 10, 1981)
  • K811701 — CHLORIDE/CARBON DIOXIDE RATE REAGENT (July 1, 1981)

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