510(k) K972861

IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) by Instrumentation Laboratory CO — Product Code JJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1997
Date Received
August 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controls For Blood-Gases, (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type