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510(k) K802654

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

K802654 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "AMES TDA PRIMIDONE TEST". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code DJD (Enzyme Immunoassay, Primidone), a Class II device regulated under 21 CFR 862.3680. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1980
Date Received
October 24, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme 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)
  • K865053 — SERA-TEK MICROSOMAL ANTIBODY TEST (February 18, 1987)

Other clearances for product code DJD

  • K973582 — ACE PRIMIDONE REAGENT, AED CALIBRATORS (November 12, 1997)
  • K910527 — EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE (March 14, 1991)
  • K840939 — EMIT QST PRIMIDONE ASSAY (April 24, 1984)
  • K832798 — MODIFICA-OF EMIT AED PRIMIDONE ASSAY (October 14, 1983)
  • K820138 — PRIMIDONE REAGENT TEST KIT (January 28, 1982)
  • K813597 — TDX PRIMIDONE (January 22, 1982)
  • K781957 — ANALYTICAL TEST PACK, PRIMIDONE (January 10, 1979)

FDA data resources