The following data is part of a premarket notification filed by Hyland Therapeutic Div., Travenol Laboratories with the FDA for Las-r Human C1 Esterase Inhibitor Test.
| Device ID | K780335 |
| 510k Number | K780335 |
| Device Name: | LAS-R HUMAN C1 ESTERASE INHIBITOR TEST |
| Classification | Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control |
| Applicant | HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DBA |
| CFR Regulation Number | 866.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-28 |
| Decision Date | 1978-03-22 |