IMMUCHEM COVALENT COAT SOLID PHASE ASSAY

Radioimmunoassay, Total Thyroxine

IMMUCHEM CORP.

The following data is part of a premarket notification filed by Immuchem Corp. with the FDA for Immuchem Covalent Coat Solid Phase Assay.

Pre-market Notification Details

Device IDK791664
510k NumberK791664
Device Name:IMMUCHEM COVALENT COAT SOLID PHASE ASSAY
ClassificationRadioimmunoassay, Total Thyroxine
Applicant IMMUCHEM CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDX  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-08-21
Decision Date1979-09-27

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