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510(k) K823741

ADVANCE EMIT-AED PRIMEDONE ASSAY by Syva Co. — Product Code LFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1983
Date Received
December 13, 1982
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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  • K993983 — SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL (January 27, 2000)
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Other clearances for product code LFT

  • K950028 — PRIMIDONE FPIA REAGENT SET AND CALIBRATORS (March 21, 1995)
  • K904683 — STRATUS PRIMIDONE FLUOROMETRIC ENZYME (November 28, 1990)
  • 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)
  • K822229 — PRIMIDONE FLUORESCENT IMMUNOASSAY (August 12, 1982)
  • K811007 — AMES TDA TM PRIMIDONE TEST (April 29, 1981)