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510(k) K863915

SHAPE-ACTIO METAL TOXICOLOGY CONTROL by Shape Products Co. — Product Code DIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1986
Date Received
October 8, 1986
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 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)
  • K890721 — SHAPE-ACTIO METAL TOXICOLOGY CONTROL (April 10, 1989)