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510(k) K021924

MEDICA EASYQC HEMATOCRIT CONTROL by Bionostics, Inc. — Product Code GLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2002
Date Received
June 11, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Hematocrit
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

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Other clearances for product code GLK

  • K121467 — EUROTROL HEMATOCRIT CONTROL (May 10, 2013)
  • K020618 — AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL (May 14, 2002)
  • K964452 — HEMATACHEK (February 20, 1997)
  • K961807 — CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 (July 26, 1996)
  • K924926 — MSI-HCT (January 7, 1993)
  • K893562 — A.QC HCT LEVEL 1 AND 2 (July 14, 1989)