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510(k) K912842

RSV-MAB TEST by Gull Laboratories, Inc. — Product Code LKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1991
Date Received
June 26, 1991
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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