The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Ca-1511, In Vitro Radioimmunoassay.
Device ID | K841821 |
510k Number | K841821 |
Device Name: | CA-1511, IN VITRO RADIOIMMUNOASSAY |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-02 |
Decision Date | 1984-06-22 |