The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Pharmacia B2-micro Ria.
Device ID | K880719 |
510k Number | K880719 |
Device Name: | PHARMACIA B2-MICRO RIA |
Classification | System, Test, Beta-2-microglobulin Immunological |
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 | JZG |
CFR Regulation Number | 866.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-23 |
Decision Date | 1988-04-21 |