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510(k) K002010

STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 by OraSure Technologies, Inc. — Product Code DJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2000
Date Received
July 3, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Methadone
Device Class
Class II
Regulation Number
862.3620
Review Panel
TX
Submission Type

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  • K151441 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (June 29, 2015)
  • K131232 — WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) (May 31, 2013)
  • K092272 — RANDOX METHADONE ASSAY (November 18, 2010)
  • K092258 — RANDOX METABOLITE (EDDP) ASSAY (November 9, 2010)