The following data is part of a premarket notification filed by Helena Laboratories with the FDA for A,a2 Lyophilized Hemo Control.
| Device ID | K800854 |
| 510k Number | K800854 |
| Device Name: | A,A2 LYOPHILIZED HEMO CONTROL |
| Classification | System, Analysis, Electrophoretic Hemoglobin |
| Applicant | HELENA LABORATORIES 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 | 1980-04-15 |
| Decision Date | 1980-04-29 |