The following data is part of a premarket notification filed by Harleco with the FDA for Ultra Zyme Plus Gpt, #64956, 65035 & 36.
| Device ID | K812591 |
| 510k Number | K812591 |
| Device Name: | ULTRA ZYME PLUS GPT, #64956, 65035 & 36 |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-11 |
| Decision Date | 1981-09-24 |