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510(k) K063209

HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL by Thermo Electron OY — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2007
Date Received
October 23, 2006
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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  • K063838 — LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH (September 27, 2007)
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  • K063150 — COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL (March 19, 2007)
  • K063647 — CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH (March 12, 2007)
  • K061107 — DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 (August 8, 2006)

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