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510(k) K960526

PRIMIDONE EIA TEST by Diagnostic Reagents, Inc. — Product Code DJP

K960526 is an FDA 510(k) premarket notification submitted by Diagnostic Reagents, Inc. for the device "PRIMIDONE EIA TEST". The FDA issued a decision of Substantially Equivalent on March 18, 1996. The device falls under product code DJP (Radioimmunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Diagnostic Reagents, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1996
Date Received
February 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Diagnostic Reagents, Inc.

  • K983268 — MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY (November 18, 1998)
  • K983812 — NAPA EIA ASSAY (November 16, 1998)
  • K983323 — DIGOXIN IMMUNOASSAY (November 12, 1998)
  • K983280 — VANCOMYCIN EIA ASSAY (November 6, 1998)
  • K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS (November 5, 1998)
  • K973102 — LIDOCAINE EIA ASSAY (September 12, 1997)
  • K972835 — 50NG/ML COCAINE METABOLITE CALIBRATOR (August 28, 1997)
  • K972526 — METHADONE EIA ASSAY (August 4, 1997)
  • K964212 — QUINIDINE ENZYME IMMUNOASSAY (December 18, 1996)
  • K963835 — DIGOXIN ENZYME IMMUNOASSAY (December 10, 1996)

Other clearances for product code DJP

  • K913866 — URINE AMPHETAMINE DIRECT RIA KIT (I-125) (September 25, 1991)
  • K912755 — ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE (August 26, 1991)
  • K882228 — REVISED DOUBLE ANTIBODY AMPHETAMINE (August 8, 1988)
  • K881817 — ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES (July 29, 1988)
  • K854009 — ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP (October 15, 1985)
  • K830482 — ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (March 24, 1983)
  • K823212 — ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE (November 29, 1982)
  • K812986 — AGGLUTEX AMPHETAMINE TEST KIT (January 22, 1982)

FDA data resources