Home / 510(k) Clearances / K811007

510(k) K811007

AMES TDA TM PRIMIDONE TEST by Miles Laboratories, Inc. — Product Code LFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1981
Date Received
April 14, 1981
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 Miles Laboratories, Inc.

  • K880605 — LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER (May 26, 1988)
  • K874909 — MICRO-BUMINTEST REAGENT TABLETS (April 28, 1988)
  • K875079 — MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE (April 5, 1988)
  • K871835 — GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT (December 22, 1987)
  • K872120 — SERALYZER III BLOOD CHEMISTRY ANALYZER (October 28, 1987)
  • K873304 — CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (September 11, 1987)
  • K872634 — CUTTER PUREFLO PLUS IV FILTER (August 4, 1987)
  • K870214 — MODIFIED SALTEX REAGENT STRIPS (June 29, 1987)
  • K870752 — SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (April 14, 1987)
  • K864530 — SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (February 18, 1987)

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)
  • K822229 — PRIMIDONE FLUORESCENT IMMUNOASSAY (August 12, 1982)