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510(k) K932482

MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 by Medix Biotech, Inc. — Product Code GTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1994
Date Received
May 24, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K920299 — MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT (March 4, 1992)

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