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510(k) K800090

FLUOROMATIC PHENOLBARBITAL FIA by Bio-Rad — Product Code DKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1980
Date Received
January 14, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
Review Panel
TX
Submission Type

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Other clearances for product code DKP

  • K844167 — ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT (November 27, 1984)
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