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510(k) K051968

ABL8X7 FLEX by Radiometer Medical Aps — Product Code CGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2006
Date Received
July 20, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Based, Enzymatic, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

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Other clearances for product code CGL

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  • K991727 — STAT PROFILE M7 ANALYZER (July 16, 1999)
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  • K903034 — RENALYZER PRX 90 (March 13, 1991)