FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH— 510(k) K872627

Name: FDA 510(k) clearance K872627
Creator: U.S. Food and Drug Administration
Published: 1987-07-21

Substantially Equivalent

Serono Diagnostics, Inc.

FDA 510(k) clearance K872627 for FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH, Substantially Equivalent on 1987-07-21. Applicant: Serono Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1987-07-06
Decision date: 1987-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

Download summary PDF View on FDA.gov ↗

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