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510(k) K021172

RSV OIA by Thermo Biostar, Inc. — Product Code GOG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2002
Date Received
April 12, 2002
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

Other clearances by Thermo Biostar, Inc.

  • K032330 — CT OIA (March 2, 2004)
  • K023947 — GC OIA (April 17, 2003)
  • K023556 — FLU OIA A/B TEST KIT (March 27, 2003)
  • K023779 — RSV OIA (January 14, 2003)

Other clearances for product code GOG

  • K071101 — TRU RSV (October 18, 2007)
  • K853278 — POLIO TYPE I CF ANTIGEN, & TYPE II, III (November 7, 1985)