The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Alanine Amino Transferase (colorimetric Method).
| Device ID | K883387 |
| 510k Number | K883387 |
| Device Name: | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) |
| Classification | Hydrazone Colorimetry, Alt/sgpt |
| Applicant | TECH-CO, INC. 24111 BEVERLY Oak Park, MI 48237 |
| Contact | Chen, Phd |
| Correspondent | Chen, Phd TECH-CO, INC. 24111 BEVERLY Oak Park, MI 48237 |
| Product Code | CKD |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-10 |
| Decision Date | 1988-10-13 |