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510(k) K082661

BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A by Princeton BioMeditech Corp. — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2008
Date Received
September 12, 2008
Clearance Type
Special
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

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