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510(k) K060215

ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 by Eurotrol B.V. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2006
Date Received
January 27, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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