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510(k) K882228

REVISED DOUBLE ANTIBODY AMPHETAMINE by Diagnostic Products Corp. — Product Code DJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1988
Date Received
May 19, 1988
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

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  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (October 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

Other clearances for product code DJP

  • K960526 — PRIMIDONE EIA TEST (March 18, 1996)
  • K913866 — URINE AMPHETAMINE DIRECT RIA KIT (I-125) (September 25, 1991)
  • K912755 — ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE (August 26, 1991)
  • 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)