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510(k) K854166

HEMATOLOGY CALIBRATOR CONTROL by Interscience Diagnostics, Inc. — Product Code KRZ

K854166 is an FDA 510(k) premarket notification submitted by Interscience Diagnostics, Inc. for the device "HEMATOLOGY CALIBRATOR CONTROL". The FDA issued a decision of Substantially Equivalent on March 12, 1986. The device falls under product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement), a Class II device regulated under 21 CFR 864.8165. Interscience Diagnostics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1986
Date Received
October 15, 1985
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 Interscience Diagnostics, Inc.

  • K842070 — IDD DETERGENT (July 2, 1984)
  • K842068 — IDI ISOTONIC DILUENT (July 2, 1984)
  • K842069 — IDL-LYSING REAGENT (July 2, 1984)

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)
  • K883703 — MSI-CAL 7 (November 22, 1988)
  • K883850 — MSI-CAL 16 (November 22, 1988)
  • K883851 — MSI-CAL 8 (November 22, 1988)

FDA data resources