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510(k) K934693

AMPHETAMINE TEST SYSTEM by U.S. Drug Testing, Inc. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1993
Date Received
September 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by U.S. Drug Testing, Inc.

  • K940912 — USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500 (June 2, 1994)
  • K935629 — USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400 (April 12, 1994)
  • K932318 — USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200 (June 15, 1993)
  • K931227 — USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 (May 6, 1993)
  • K930985 — USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100 (April 27, 1993)

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