The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Avl 9181 Electrolyte Analyzer.
Device ID | K972673 |
510k Number | K972673 |
Device Name: | AVL 9181 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 | 1997-07-16 |
Decision Date | 1997-08-20 |
Summary: | summary |