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510(k) K021924

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

K021924 is an FDA 510(k) premarket notification submitted by Bionostics, Inc. for the device "MEDICA EASYQC HEMATOCRIT CONTROL". The FDA issued a decision of Substantially Equivalent on June 24, 2002. The device falls under product code GLK (Control, Hematocrit), a Class II device regulated under 21 CFR 864.8625. Bionostics, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Bionostics, Inc.

  • K131136 — GLUCOSE METER-CHECK SOLUTION FOR TAIDOC (May 31, 2013)
  • K123851 — GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK (February 14, 2013)
  • K123966 — GLUCOSE METER-CHECK SOLUTION FOR BAYER (January 25, 2013)
  • K113764 — GLUCOSE METER-CHECK SOLUTION FOR INFOPIA (January 30, 2012)
  • K112352 — GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT (December 23, 2011)
  • K112356 — GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE (September 19, 2011)
  • K103553 — LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION (February 10, 2011)
  • K101831 — ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 (October 1, 2010)
  • K091914 — OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION (November 6, 2009)
  • K081478 — RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS (October 6, 2008)

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)

FDA data resources