510(k) K791287

MEDICOR QUALITY CONTROL BUFFER by Medicor USA , Ltd. — Product Code JJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1979
Date Received
July 10, 1979
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