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510(k) K810144

ALK-PHOS BIOPAK GEL by Bioware Products — Product Code CIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1981
Date Received
January 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

Other clearances by Bioware Products

  • K802299 — K/K (ASMA/ANA) UNIVERSAL BIOPAK (January 29, 1981)
  • K802308 — T/K (ATA/AMA) UNIVERSAL BIOPAK (December 1, 1980)
  • K802276 — FTA-ABS BIOPAK (October 23, 1980)

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  • K981373 — ALKPHASE-B ASSAY KIT (May 27, 1998)
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