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510(k) K946090

KODAK EKTACCHEM 950IRC ANALYZER by Clinical Diagnostic Systems, Inc. — Product Code JJE

K946090 is an FDA 510(k) premarket notification submitted by Clinical Diagnostic Systems, Inc. for the device "KODAK EKTACCHEM 950IRC ANALYZER". The FDA issued a decision of Substantially Equivalent on January 17, 1995. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1995
Date Received
December 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

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FDA data resources