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510(k) K020610

LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 by Bio-Rad — Product Code DIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2002
Date Received
February 25, 2002
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

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Other clearances for product code DIE

  • 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)
  • K863915 — SHAPE-ACTIO METAL TOXICOLOGY CONTROL (November 24, 1986)