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510(k) K811381

ASTRA by Chem-Elec, Inc. — Product Code JFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1981
Date Received
May 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ph Rate Measurement, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

Other clearances by Chem-Elec, Inc.

  • K943503 — CHEMCARD GLUCOSE TEST (July 23, 1996)
  • K864159 — SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD (June 10, 1988)
  • K811165 — GLUCOSE OXIDASE RATE REAGENT (August 13, 1981)
  • K811319 — CHLORIDE REAGENT KIT (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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