The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Avl Ise-trol Electrolyte Control.
| Device ID | K863333 |
| 510k Number | K863333 |
| Device Name: | AVL ISE-TROL ELECTROLYTE CONTROL |
| Classification | Electrolyte Controls (assayed And Unassayed) |
| 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 | JJR |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-28 |
| Decision Date | 1986-09-29 |