The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Phadirect Strep A Test.
| Device ID | K854150 |
| 510k Number | K854150 |
| Device Name: | PHADIRECT STREP A TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
| Contact | Brian D Bollwage |
| Correspondent | Brian D Bollwage PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-11 |
| Decision Date | 1985-10-23 |