PROGESTERONE RADIOIMMUNOASSAY KIT

Radioimmunoassay, Progesterone

CIS RADIOPHARMACEUTICALS, INC.

The following data is part of a premarket notification filed by Cis Radiopharmaceuticals, Inc. with the FDA for Progesterone Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK791051
510k NumberK791051
Device Name:PROGESTERONE RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Progesterone
Applicant CIS RADIOPHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJLS  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-06-06
Decision Date1979-07-24

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