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510(k) K041230

CLINICAL LABORATORY ANALYZING SYSTEM by Hemocue, Inc. — Product Code LFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2004
Date Received
May 10, 2004
Clearance Type
Special
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

Other clearances by Hemocue, Inc.

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  • K060765 — HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES (September 6, 2006)
  • 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)
  • 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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