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510(k) K926422

VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY by Syva Co. — Product Code GGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1993
Date Received
December 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluid, Diluting, White-Cell
Device Class
Class I
Regulation Number
864.8200
Review Panel
HE
Submission Type

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