510(k) K961458

AVL 9180 ELECTROLYTE ANALYZER by Avl Scientific Corp. — Product Code JFP

K961458 is an FDA 510(k) premarket notification submitted by Avl Scientific Corp. for the device "AVL 9180 ELECTROLYTE ANALYZER". The FDA issued a decision of Substantially Equivalent on June 12, 1996. The device falls under product code JFP (Electrode, Ion Specific, Calcium), a Class II device regulated under 21 CFR 862.1145. Avl Scientific Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1996
Date Received
April 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type