Home / 510(k) Clearances / K822229

510(k) K822229

PRIMIDONE FLUORESCENT IMMUNOASSAY by American Diagnostic Corp. — Product Code LFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1982
Date Received
July 27, 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

Other clearances by American Diagnostic Corp.

  • K162589 — Adscope 658 Electronic Stethoscope (March 10, 2017)
  • K093495 — OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS (November 19, 2010)
  • K060321 — ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK (May 15, 2006)
  • K012304 — ADC 656 ELECTRONIC STETHOSCOPE (November 1, 2001)
  • K962655 — ANEROID AND MERCURIAL SPHYGMOMANOMETERS (January 27, 1997)
  • K940686 — ELECTRONIC THERMOMETERS (July 8, 1994)
  • K935944 — PROSCOPES AND ADSCOPES (March 3, 1994)
  • K932145 — COAGULATION REFERENCE PLASMA, NORMAL (October 18, 1993)
  • K894169 — BIOTEL MICROALBUMINURIA (TM) (September 18, 1989)
  • K893608 — ACTICHROME ATIII KIT (June 23, 1989)

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)
  • K823741 — ADVANCE EMIT-AED PRIMEDONE ASSAY (January 7, 1983)
  • K811007 — AMES TDA TM PRIMIDONE TEST (April 29, 1981)