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510(k) K890442

SHAPE-ACTIO URINALYSIS CONTROLS by Actio, Inc. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1989
Date Received
January 27, 1989
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

Other clearances by Actio, Inc.

  • K902699 — SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY) (July 16, 1990)
  • K885282 — ASSAYED CHOLINESTERASE CONTROL (June 9, 1989)
  • K890721 — SHAPE-ACTIO METAL TOXICOLOGY CONTROL (April 10, 1989)

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