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510(k) K060510

DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT by Drew Scientific , Ltd. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2006
Date Received
February 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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  • K920198 — GLYCOMAT HAEMOGLOBIN ANALYSER (July 21, 1992)

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