Home / 510(k) Clearances / K895567

510(k) K895567

PRIMIDONE (FPIA) KIT by Tudor Laboratories, Inc. — Product Code LFT

K895567 is an FDA 510(k) premarket notification submitted by Tudor Laboratories, Inc. for the device "PRIMIDONE (FPIA) KIT". The FDA issued a decision of Substantially Equivalent on October 20, 1989. The device falls under product code LFT (Fluorescent Immunoassay, Primidone), a Class II device regulated under 21 CFR 862.3680. Tudor Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1989
Date Received
September 6, 1989
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 Tudor Laboratories, Inc.

  • K921904 — THYROXINE (FPIA) KIT (June 24, 1992)
  • K921903 — THYROXINE CALIBRATOR KIT (May 26, 1992)
  • K913240 — DIGITOXIN (FPIA) KIT (September 6, 1991)
  • K895572 — N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT (October 30, 1989)
  • K895571 — N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT (October 25, 1989)
  • K895569 — VALPROIC ACID (FPIA) KIT (October 3, 1989)
  • K895568 — PRIMIDONE (FPIA) CALIBRATOR KIT (September 28, 1989)
  • K895570 — VALPROIC ACID (FPIA) CALIBRATOR KIT (September 28, 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)
  • 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)

FDA data resources