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510(k) K880654

AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 by American Research Products Co. — Product Code JIW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1988
Date Received
February 17, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Surrogate
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K900571 — AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) (April 16, 1990)
  • K900394 — AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 (April 11, 1990)

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