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510(k) K872843

OVEIA (TM) DUAL ANALYTE by Boots-Celltech Diagnostics, Inc. — Product Code JLP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1988
Date Received
July 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spectrophotometric Method, Pregnanediol
Device Class
Class I
Regulation Number
862.1605
Review Panel
CH
Submission Type

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