The following data is part of a premarket notification filed by Gelman Sciences, Inc. with the FDA for Autophor 128.
| Device ID | K810047 |
| 510k Number | K810047 |
| Device Name: | AUTOPHOR 128 |
| Classification | System, Analysis, Electrophoretic Hemoglobin |
| Applicant | GELMAN SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JBD |
| CFR Regulation Number | 864.7440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-12 |
| Decision Date | 1981-02-05 |