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510(k) K920917

ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY by Bio Clinic Co. — Product Code CGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1992
Date Received
February 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Follicle-Stimulating Hormone
Device Class
Class I
Regulation Number
862.1300
Review Panel
CH
Submission Type

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