PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS

Radioimmunoassay, Prolactin (lactogen)

SERONO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for Prl Serozyme Immunoenz. Assay Kit, Mag. Solid Phas.

Pre-market Notification Details

Device IDK872862
510k NumberK872862
Device Name:PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS
ClassificationRadioimmunoassay, Prolactin (lactogen)
Applicant SERONO DIAGNOSTICS, INC. 100 LONGWATER CIRCLE Norwell,  MA  02061
ContactPhilip M Fantasia
CorrespondentPhilip M Fantasia
SERONO DIAGNOSTICS, INC. 100 LONGWATER CIRCLE Norwell,  MA  02061
Product CodeCFT  
CFR Regulation Number862.1625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-21
Decision Date1987-09-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.