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510(k) K021789

QUICKLAB RSV by Integrated Biotechnology Corp. — Product Code GQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2002
Date Received
May 31, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Device Class
Class I
Regulation Number
866.3480
Review Panel
MI
Submission Type

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