The following data is part of a premarket notification filed by Hyland Therapeutic Div., Travenol Laboratories with the FDA for Automated Enzyme.
| Device ID | K780962 |
| 510k Number | K780962 |
| Device Name: | AUTOMATED ENZYME |
| Classification | Solution, Stabilized Enzyme |
| Applicant | HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSK |
| CFR Regulation Number | 864.9400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-12 |
| Decision Date | 1978-07-27 |