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510(k) K882687

ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST by Gull Laboratories, Inc. — Product Code LKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1988
Date Received
June 30, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Device Class
Class I
Regulation Number
866.3480
Review Panel
MI
Submission Type

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