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510(k) K071101

TRU RSV by Meridian Bioscience, Inc. — Product Code GOG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2007
Date Received
April 19, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Cf, Poliovirus 1-3
Device Class
Class I
Regulation Number
866.3405
Review Panel
MI
Submission Type

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Other clearances for product code GOG

  • K021172 — RSV OIA (September 13, 2002)
  • K853278 — POLIO TYPE I CF ANTIGEN, & TYPE II, III (November 7, 1985)