SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT

Igg, Antigen, Antiserum, Control

SCRIPPS-MILES, INC.

The following data is part of a premarket notification filed by Scripps-miles, Inc. with the FDA for Scrippsystem Nephelometric Antisera Kit.

Pre-market Notification Details

Device IDK812328
510k NumberK812328
Device Name:SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT
ClassificationIgg, Antigen, Antiserum, Control
Applicant SCRIPPS-MILES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDEW  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-08-18
Decision Date1981-09-08

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