The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Pharmacia Insulin Ria.
Device ID | K851071 |
510k Number | K851071 |
Device Name: | PHARMACIA INSULIN RIA |
Classification | Radioimmunoassay, Immunoreactive Insulin |
Applicant | PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
Contact | Albert P Mayo |
Correspondent | Albert P Mayo PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
Product Code | CFP |
CFR Regulation Number | 862.1405 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-18 |
Decision Date | 1985-04-12 |