The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Phadebact Strep Positive Controls.
| Device ID | K832248 |
| 510k Number | K832248 |
| Device Name: | PHADEBACT STREP POSITIVE CONTROLS |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | PHARMACIA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-11 |
| Decision Date | 1983-09-01 |