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510(k) K884004

RUBEOLA TEST by Gull Laboratories, Inc. — Product Code GRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1988
Date Received
September 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Rubeola
Device Class
Class I
Regulation Number
866.3520
Review Panel
MI
Submission Type

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Other clearances for product code GRE

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