The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Pharmacia Ige Riact.
Device ID | K881892 |
510k Number | K881892 |
Device Name: | PHARMACIA IGE RIACT |
Classification | Ige, Antigen, Antiserum, Control |
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 | DGC |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-04 |
Decision Date | 1988-06-10 |