The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Avl Omni Analyzer.
Device ID | K945915 |
510k Number | K945915 |
Device Name: | AVL OMNI ANALYZER |
Classification | Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use |
Applicant | AVL SCIENTIFIC CORP. 33 MANSELL COURT Roswell, GA 30076 -4807 |
Contact | Randy Byrd |
Correspondent | Randy Byrd AVL SCIENTIFIC CORP. 33 MANSELL COURT Roswell, GA 30076 -4807 |
Product Code | JJC |
Subsequent Product Code | CEM |
Subsequent Product Code | CGC |
Subsequent Product Code | CHL |
Subsequent Product Code | GKF |
Subsequent Product Code | GKR |
Subsequent Product Code | JFP |
Subsequent Product Code | JGS |
CFR Regulation Number | 862.2150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-02 |
Decision Date | 1995-04-05 |