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510(k) K170481

Strep B Carrot Broth Kit by Hardy Diagnostics — Product Code PQZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2017
Date Received
February 16, 2017
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)
  • K170586 — Strep B Carrot Broth One-Step (May 22, 2017)
  • K163042 — chromID Strepto B agar (January 27, 2017)