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510(k) K020371

UPLINK TEST SYSTEM by OraSure Technologies, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2002
Date Received
February 4, 2002
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

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  • K001976 — STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I (December 6, 2000)
  • K002010 — STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 (November 29, 2000)
  • K000399 — STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 (May 15, 2000)
  • K001197 — COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA (May 11, 2000)

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