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510(k) K891691

LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II by Bio-Rad — Product Code DIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1989
Date Received
March 22, 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

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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)
  • K890721 — SHAPE-ACTIO METAL TOXICOLOGY CONTROL (April 10, 1989)
  • K863915 — SHAPE-ACTIO METAL TOXICOLOGY CONTROL (November 24, 1986)