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510(k) K163042

chromID Strepto B agar by bioMerieux, Inc. — Product Code PQZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2017
Date Received
October 31, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gbs Culture Media, Selective And Differential
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type

Culture Medium for GBS Detection

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Other clearances for product code PQZ

  • K173903 — Granada Medium (March 22, 2018)
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