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510(k) K936112

STREP B OIA by Biostar, Inc. — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1994
Date Received
December 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, All Groups, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

Other clearances by Biostar, Inc.

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  • K962060 — STREP A OIA MAX (July 23, 1997)
  • K951010 — CHLAMYDIA OIA (October 7, 1995)

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