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510(k) K041747

IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) by Lifepoint,Inc — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2004
Date Received
June 29, 2004
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 Lifepoint,Inc

  • K041746 — IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) (November 23, 2004)
  • K833737 — CPR LOCATOR (August 24, 1984)

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