PTH MR

Radioimmunoassay, Parathyroid Hormone

RAMCO LABORATORIES, INC.

The following data is part of a premarket notification filed by Ramco Laboratories, Inc. with the FDA for Pth Mr.

Pre-market Notification Details

Device IDK831470
510k NumberK831470
Device Name:PTH MR
ClassificationRadioimmunoassay, Parathyroid Hormone
Applicant RAMCO LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCEW  
CFR Regulation Number862.1545 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-06
Decision Date1983-06-22

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