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510(k) K945315

DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL by Casco Standards — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1994
Date Received
November 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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  • K962629 — DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR (September 13, 1996)
  • K961750 — DOCUMENT CARDIAC ASSAYED CONTROL (July 22, 1996)
  • K962630 — DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL (July 22, 1996)
  • K960244 — DOCUMENT TDM ULTRA ASSAYED CONTROL (March 22, 1996)
  • K955155 — DOCUMENT TDM ULTRA UNASSAYED CONTROL (December 20, 1995)
  • K950469 — DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET (April 11, 1995)
  • K945718 — DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET (January 17, 1995)
  • K944361 — DOCUMENT R AMMONIA/ETHANOL CONTROL (November 30, 1994)

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