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510(k) K022693

INSTANT-VIEW TCA URINE TEST by Alfa Scientific Designs, Inc. — Product Code MLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2002
Date Received
August 13, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Tricyclic Antidepressant Drugs
Device Class
Class II
Regulation Number
862.3910
Review Panel
TX
Submission Type

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Other clearances for product code MLK

  • K010734 — BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 (July 30, 2001)