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510(k) K946210

PHENOBARBITAL ENZYME IMMUNOASSAY by Diagnostic Reagents, Inc. — Product Code DLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1995
Date Received
December 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K972526 — METHADONE EIA ASSAY (August 4, 1997)
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  • K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (January 27, 2000)
  • K984288 — VITROS CHEMISTRY PRODUCTS PHBR SLIDES (January 26, 1999)
  • K943981 — IL TEST PHENOBARBITAL CALIBRATORS (January 18, 1995)