The following data is part of a premarket notification filed by Hyland Therapeutic Div., Travenol Laboratories with the FDA for Alert A,hdl-apoliporotein A, Test Kit.
| Device ID | K802610 |
| 510k Number | K802610 |
| Device Name: | ALERT A,HDL-APOLIPOROTEIN A, TEST KIT |
| Classification | Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Applicant | HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DER |
| CFR Regulation Number | 866.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-21 |
| Decision Date | 1981-01-05 |