Home / 510(k) Clearances / K842668

510(k) K842668

LIQUI-HEME HEMOGLOBIN CALIBRATORS by Biodiagnostic Intl — Product Code KRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1985
Date Received
July 10, 1984
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 Biodiagnostic Intl

  • K031296 — LIQUI-HEME GLYCO A1C ASSAY (October 15, 2004)
  • K881430 — LIQUI-SERA SERUM ALCOHOL CONTROLS (July 8, 1988)
  • K874459 — LIQUI-SERA SPINAL FLUID CONTROL (December 29, 1987)
  • K863849 — LIQUI-SERA COMBO LIGAND/TDM CONTROLS (November 24, 1986)
  • K853906 — LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) (October 4, 1985)
  • K853887 — LIQUI-SERA CHEM. MULTIPLE CALIBRATORS (September 30, 1985)
  • K840618 — LIQUI-URA CHEMISTRY URINE CONTROLS (April 4, 1984)
  • K834398 — LIQUI-SERA TDM CALIBRATORS (February 3, 1984)
  • K834259 — LIQUI-URA TOXIC URINE CONTROL (January 30, 1984)
  • K831278 — LIQUI-SERA ANTICONVULSANTS CONTROLS (May 27, 1983)

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