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510(k) K972481

AUTO-LYTE COTININE EIA by OraSure Technologies, Inc. — Product Code MKU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1997
Date Received
July 2, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Device Class
Class I
Regulation Number
862.3220
Review Panel
TX
Submission Type

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  • K002375 — STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I (January 26, 2001)
  • 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)

Other clearances for product code MKU

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  • K021944 — COZART EIA COTININE URINE KIT (May 14, 2003)
  • K974534 — MICRO-PLATE COTININE EIA (May 18, 1998)
  • K974234 — MICRO-PLATE COTININE EIA (May 14, 1998)