510(k) K884771

IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY by Instrumentation Laboratory CO — Product Code JFP

K884771 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY". The FDA issued a decision of Substantially Equivalent on February 10, 1989. The device falls under product code JFP (Electrode, Ion Specific, Calcium), a Class II device regulated under 21 CFR 862.1145. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1989
Date Received
November 14, 1988
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