The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Avl Model 985 Electrolyte Analyzer.
| Device ID | K870657 |
| 510k Number | K870657 |
| Device Name: | AVL MODEL 985 ELECTROLYTE ANALYZER |
| Classification | Electrode, Ion Specific, Potassium |
| 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 | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-18 |
| Decision Date | 1987-05-12 |