The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Delfia(tm) Neonatal Htsh Kit.
| Device ID | K881627 |
| 510k Number | K881627 |
| Device Name: | DELFIA(TM) 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 | 1988-04-12 |
| Decision Date | 1988-10-03 |