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510(k) K952802

VISUWELL REAGIN II by Biomira Diagnostics, Inc. — Product Code GMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1996
Date Received
June 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Nontreponemal, All
Device Class
Class II
Regulation Number
866.3820
Review Panel
MI
Submission Type

Other clearances by Biomira Diagnostics, Inc.

  • K932453 — VISUWELL SYPHILIS ANTIBODY (July 11, 1995)

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