CA-1511, IN VITRO RADIOIMMUNOASSAY

Visual, Pregnancy Hcg, Prescription Use

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Ca-1511, In Vitro Radioimmunoassay.

Pre-market Notification Details

Device IDK841821
510k NumberK841821
Device Name:CA-1511, IN VITRO RADIOIMMUNOASSAY
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-02
Decision Date1984-06-22

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