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510(k) K890721

SHAPE-ACTIO METAL TOXICOLOGY CONTROL by Actio, Inc. — Product Code DIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1989
Date Received
February 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heavy Metals Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by Actio, Inc.

  • K902699 — SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY) (July 16, 1990)
  • K885282 — ASSAYED CHOLINESTERASE CONTROL (June 9, 1989)
  • K890442 — SHAPE-ACTIO URINALYSIS CONTROLS (March 8, 1989)

Other clearances for product code DIE

  • K020610 — LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 (April 22, 2002)
  • K990928 — LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 (April 16, 1999)
  • K891691 — LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II (December 19, 1989)
  • K863915 — SHAPE-ACTIO METAL TOXICOLOGY CONTROL (November 24, 1986)