The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Avl Omni Analyzer.
| Device ID | K954018 |
| 510k Number | K954018 |
| Device Name: | AVL OMNI ANALYZER |
| Classification | System, Hemoglobin, Automated |
| 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 | GKR |
| Subsequent Product Code | GHS |
| Subsequent Product Code | GKF |
| Subsequent Product Code | GLY |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-25 |
| Decision Date | 1995-10-05 |