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510(k) K010921

ADVANTAGE MARIJUANA (THC) HOME DRUG TEST by Advantage Diagnostics Corp. — Product Code LDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2001
Date Received
March 27, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

Other clearances by Advantage Diagnostics Corp.

  • K023712 — ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST (January 31, 2003)
  • K013778 — PEACE OF MIND HOME DRUG TEST (February 7, 2002)
  • K011962 — ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST (August 9, 2001)
  • K003708 — ADVANTAGE THC/COCAINE TEST (January 22, 2001)
  • K001567 — ADVANTAGE THC TEST (June 19, 2000)
  • K994227 — ADVANTAGE HCG TEST (URINE/SERUM) (February 3, 2000)
  • K991883 — REDI-TEST OPIATES (September 15, 1999)
  • K903416 — CANNULA, SURGICAL (November 23, 1990)
  • K881369 — ADVANCE DIAGNOSTICS DISPOSABLE EYECUP (May 13, 1988)

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