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510(k) K874389

CRACK-IT CHAP SCREEN by Sakers, Inc. — Product Code DMN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1989
Date Received
October 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Cocaine
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

Other clearances by Sakers, Inc.

  • K874390 — CRACK-IT CANNABINOID SCREEN (April 10, 1989)

Other clearances for product code DMN

  • K972618 — QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070) (August 8, 1997)