The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Pharmacia Delfia Neonatal Htsh Kit.
Device ID | K905710 |
510k Number | K905710 |
Device Name: | PHARMACIA DELFIA NEONATAL HTSH KIT |
Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
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 | JLW |
CFR Regulation Number | 862.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-21 |
Decision Date | 1991-02-21 |