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 |