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510(k) K860900

IMMPULSE FREE ESTRIOL ASSAY REAGENTS by Sclavo, Inc. — Product Code CGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1986
Date Received
March 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Estriol
Device Class
Class I
Regulation Number
862.1265
Review Panel
CH
Submission Type

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  • K850787 — SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY (March 26, 1985)
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