The following data is part of a premarket notification filed by Genetic Systems Corp. with the FDA for Alanine Transaminase (alt) Test Kit.
| Device ID | K870879 |
| 510k Number | K870879 |
| Device Name: | ALANINE TRANSAMINASE (ALT) TEST KIT |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| Applicant | GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle, WA 98121 |
| Contact | Krieger, Phd |
| Correspondent | Krieger, Phd GENETIC SYSTEMS CORP. 3005 FIRST AVE. Seattle, WA 98121 |
| Product Code | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-04 |
| Decision Date | 1987-03-19 |