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510(k) K802308

T/K (ATA/AMA) UNIVERSAL BIOPAK by Bioware Products — Product Code DBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1980
Date Received
September 23, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5090
Review Panel
IM
Submission Type

Other clearances by Bioware Products

  • K810144 — ALK-PHOS BIOPAK GEL (February 2, 1981)
  • K802299 — K/K (ASMA/ANA) UNIVERSAL BIOPAK (January 29, 1981)
  • K802276 — FTA-ABS BIOPAK (October 23, 1980)

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