The following data is part of a premarket notification filed by Cis-us, Inc. with the FDA for Elsa-hct.
Device ID | K951708 |
510k Number | K951708 |
Device Name: | ELSA-HCT |
Classification | Radioimmunoassay, Calcitonin |
Applicant | CIS-US, INC. 10 DE ANGELO DR. Bedford, MA 01730 |
Contact | Mary E Donovan |
Correspondent | Mary E Donovan CIS-US, INC. 10 DE ANGELO DR. Bedford, MA 01730 |
Product Code | JKR |
Subsequent Product Code | JIT |
Subsequent Product Code | JJX |
CFR Regulation Number | 862.1140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-13 |
Decision Date | 1995-09-05 |