The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Miles Alanine Aminotransferase Sera-pak Method.
| Device ID | K920335 |
| 510k Number | K920335 |
| Device Name: | MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| Applicant | HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Thomas Brewster |
| Correspondent | Thomas Brewster HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-24 |
| Decision Date | 1992-03-24 |