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 |