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510(k) K932318

USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200 by U.S. Drug Testing, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1993
Date Received
May 11, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
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)
  • K934693 — AMPHETAMINE TEST SYSTEM (November 22, 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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