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510(k) K811406

CREATININE RATE REAGENT KIT by Chem-Elec, Inc. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1981
Date Received
May 19, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Chem-Elec, Inc.

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  • K864159 — SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD (June 10, 1988)
  • K811381 — ASTRA (August 13, 1981)
  • K811319 — CHLORIDE REAGENT KIT (August 13, 1981)
  • K811165 — GLUCOSE OXIDASE RATE REAGENT (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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