The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Somatomedin-c Radioimmunoassay Kit.
Device ID | K841088 |
510k Number | K841088 |
Device Name: | SOMATOMEDIN-C RADIOIMMUNOASSAY KIT |
Classification | Radioimmunoassay, Human Growth Hormone |
Applicant | NICHOLS INSTITUTE DIAGNOSTICS P.O. BOX 92797 Los Angeles, CA 90009 |
Contact | Elaine Walton |
Correspondent | Elaine Walton NICHOLS INSTITUTE DIAGNOSTICS P.O. BOX 92797 Los Angeles, CA 90009 |
Product Code | CFL |
CFR Regulation Number | 862.1370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-13 |
Decision Date | 1984-10-22 |