The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Staphylococcal Protein A Insoluble.
| Device ID | K812181 |
| 510k Number | K812181 |
| Device Name: | STAPHYLOCOCCAL PROTEIN A INSOLUBLE |
| Classification | Staphylococcus Aureus Protein A Insoluble |
| Applicant | OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LHJ |
| CFR Regulation Number | 866.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-03 |
| Decision Date | 1981-08-25 |