Home / 510(k) Clearances / K982831

510(k) K982831

AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U by OraSure Technologies, Inc. — Product Code JXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1998
Date Received
August 11, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Benzodiazepine
Device Class
Class II
Regulation Number
862.3170
Review Panel
TX
Submission Type

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  • K002010 — STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 (November 29, 2000)
  • K000399 — STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541 (May 15, 2000)

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