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510(k) K820138

PRIMIDONE REAGENT TEST KIT by Beckman Instruments, Inc. — Product Code DJD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1982
Date Received
January 18, 1982
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 Beckman Instruments, Inc.

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  • K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT (May 8, 1998)
  • K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 (May 1, 1998)
  • K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 (March 18, 1998)
  • K974816 — ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 (February 20, 1998)
  • K974564 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT (February 17, 1998)
  • K974110 — IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (December 24, 1997)
  • K974452 — VIGIL LIPID CONTROL (December 17, 1997)
  • K973932 — BECKMAN CALIBRATOR 2 (CAL2) (December 15, 1997)

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)
  • K813597 — TDX PRIMIDONE (January 22, 1982)
  • K802654 — AMES TDA PRIMIDONE TEST (November 12, 1980)
  • K781957 — ANALYTICAL TEST PACK, PRIMIDONE (January 10, 1979)