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510(k) K904683

STRATUS PRIMIDONE FLUOROMETRIC ENZYME by Baxter Healthcare Corp — Product Code LFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1990
Date Received
October 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Immunoassay, Primidone
Device Class
Class II
Regulation Number
862.3680
Review Panel
TX
Submission Type

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Other clearances for product code LFT

  • K950028 — PRIMIDONE FPIA REAGENT SET AND CALIBRATORS (March 21, 1995)
  • K895567 — PRIMIDONE (FPIA) KIT (October 20, 1989)
  • K852318 — COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS (June 25, 1985)
  • K842196 — STRATUS PRIMIDONE FLOROMETRIC ENZY (July 11, 1984)
  • K823741 — ADVANCE EMIT-AED PRIMEDONE ASSAY (January 7, 1983)
  • K822229 — PRIMIDONE FLUORESCENT IMMUNOASSAY (August 12, 1982)
  • K811007 — AMES TDA TM PRIMIDONE TEST (April 29, 1981)