The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Phadebact Etec-lt Test.
Device ID | K874288 |
510k Number | K874288 |
Device Name: | PHADEBACT ETEC-LT TEST |
Classification | Antisera, All Types, Escherichia Coli |
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 | GNA |
CFR Regulation Number | 866.3255 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-20 |
Decision Date | 1988-09-02 |