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510(k) K903223

ON-SITE ALCOHOL by Toxi-Lab, Inc. — Product Code DOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1991
Date Received
July 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Potassium Dichromate, Alcohol
Device Class
Class II
Regulation Number
862.3040
Review Panel
TX
Submission Type

Other clearances by Toxi-Lab, Inc.

  • K932209 — TOXI*LAB LTD OPIATE SYSTEM (September 24, 1993)
  • K923337 — ON*SITE ALCOHOL (January 12, 1993)
  • K901694 — SPEC(TM) EXTRACTION CARTRIDGE (June 1, 1990)
  • K900626 — ALPHA URINE SAMPLE (March 6, 1990)

Other clearances for product code DOJ

  • K792469 — INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS (January 23, 1980)