The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Avl 9180 Electrolyte Analyzer.
| Device ID | K961458 |
| 510k Number | K961458 |
| Device Name: | AVL 9180 ELECTROLYTE ANALYZER |
| Classification | Electrode, Ion Specific, Calcium |
| 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 | JFP |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIH |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-15 |
| Decision Date | 1996-06-12 |
| Summary: | summary |