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510(k) K060765

HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 by Hemocue AB — Product Code LFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2006
Date Received
March 21, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Dehydrogenase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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  • K061047 — HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 (June 8, 2006)
  • K053253 — HEMOCUE ALBUMIN 201 ANALYZING SYSTEM (February 17, 2006)
  • K041234 — HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM (June 10, 2004)
  • K041230 — CLINICAL LABORATORY ANALYZING SYSTEM (May 20, 2004)
  • K032203 — HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 (August 25, 2003)
  • K020935 — HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 (April 3, 2002)
  • K962415 — HEMOCUE B-GLCOSE SYSTEM (October 15, 1996)

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