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510(k) K865014

LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II by Bio-Rad — Product Code DGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1987
Date Received
December 23, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Whole Human Serum, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5700
Review Panel
HE
Submission Type

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Other clearances for product code DGR

  • K961544 — QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 (September 24, 1996)
  • K902220 — PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL (September 5, 1990)
  • K790298 — RADIOASSAY, CONTROL SERUM I, II, III (April 4, 1979)
  • K781355 — ICS NORMAL CONTROL SERUM (August 31, 1978)