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510(k) K831872

CALIBRATOR 282 by Bionostics, Inc. — Product Code KRZ

K831872 is an FDA 510(k) premarket notification submitted by Bionostics, Inc. for the device "CALIBRATOR 282". The FDA issued a decision of Substantially Equivalent on July 18, 1983. The device falls under product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement), a Class II device regulated under 21 CFR 864.8165. Bionostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1983
Date Received
June 13, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator For Hemoglobin And Hematocrit Measurement
Device Class
Class II
Regulation Number
864.8165
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 KRZ

  • K052101 — C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C (August 26, 2005)
  • K041130 — CDS HEMATOLOGY CALIBRATOR (CDS CAL) (June 10, 2004)
  • K962864 — THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS (December 18, 1996)
  • K951071 — ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS (July 24, 1995)
  • K902892 — CELL-DYN CALIBRATOR (September 10, 1990)
  • K896921 — RAICHEM TM HEMOGLOBIN CALIBRATOR (January 25, 1990)
  • K893984 — HGB-CAL SET/MULTIPLE (August 15, 1989)
  • K883850 — MSI-CAL 16 (November 22, 1988)
  • K883703 — MSI-CAL 7 (November 22, 1988)
  • K883851 — MSI-CAL 8 (November 22, 1988)

FDA data resources