The following data is part of a premarket notification filed by North American Biologicals, Inc. with the FDA for Blood Group Substance B.
| Device ID | K781895 |
| 510k Number | K781895 |
| Device Name: | BLOOD GROUP SUBSTANCE B |
| Classification | Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use |
| Applicant | NORTH AMERICAN BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSX |
| CFR Regulation Number | 864.9160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-06 |
| Decision Date | 1978-12-20 |