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510(k) K941221

DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE by Dupont Medical Products — Product Code CGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1994
Date Received
March 14, 1994
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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