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510(k) K900626

ALPHA URINE SAMPLE by Toxi-Lab, Inc. — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1990
Date Received
February 8, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Mixture Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by Toxi-Lab, Inc.

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  • K903223 — ON-SITE ALCOHOL (March 13, 1991)
  • K901694 — SPEC(TM) EXTRACTION CARTRIDGE (June 1, 1990)

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