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510(k) K990928

LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 by Bio-Rad — Product Code DIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1999
Date Received
March 19, 1999
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)
  • 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)