510(k) K980757

ILAB 600 CLINICAL CHEMISTRY SYSTEM by Instrumentation Laboratory CO — Product Code CGZ

K980757 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "ILAB 600 CLINICAL CHEMISTRY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 21, 1998. The device falls under product code CGZ (Electrode, Ion-Specific, Chloride), a Class II device regulated under 21 CFR 862.1170. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1998
Date Received
February 27, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion-Specific, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type