The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Avl Model 983 Electrolyte Analyzer.
Device ID | K861087 |
510k Number | K861087 |
Device Name: | AVL MODEL 983 ELECTROLYTE ANALYZER |
Classification | Electrode, Ion Specific, Sodium |
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 | JGS |
CFR Regulation Number | 862.1665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-21 |
Decision Date | 1986-04-07 |