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510(k) K885282

ASSAYED CHOLINESTERASE CONTROL by Actio, Inc. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1989
Date Received
December 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
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)
  • K890721 — SHAPE-ACTIO METAL TOXICOLOGY CONTROL (April 10, 1989)
  • K890442 — SHAPE-ACTIO URINALYSIS CONTROLS (March 8, 1989)

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