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510(k) K050178

HBA1C ENZYMATIC ASSAY by General Atomics — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2005
Date Received
January 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

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  • K033360 — DIAZYME LITHIUM ENZYMATIC ASSAY KIT (December 23, 2003)

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