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510(k) K962864

THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS by Alko Diagnostic Corp. — Product Code KRZ

K962864 is an FDA 510(k) premarket notification submitted by Alko Diagnostic Corp. for the device "THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS". The FDA issued a decision of Substantially Equivalent on December 18, 1996. The device falls under product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement), a Class II device regulated under 21 CFR 864.8165. Alko Diagnostic Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1996
Date Received
July 23, 1996
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 Alko Diagnostic Corp.

  • K001484 — CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; (June 19, 2000)
  • K982501 — ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID R (September 1, 1998)
  • K972004 — ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS (June 16, 1997)
  • K970921 — STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (April 8, 1997)
  • K963734 — ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS (October 24, 1996)
  • K960085 — ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS (March 11, 1996)
  • K955154 — CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT (December 11, 1995)
  • K951071 — ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS (July 24, 1995)
  • K950902 — ALKO TONOMETERED SALINE CONTROL (March 30, 1995)
  • K944922 — ALKO CAL PACKS FOR CORNING 654 ANALYZERS (February 10, 1995)

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)
  • 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)
  • K882600 — HEMOCUE HEMOGLOBIN CALIBRATOR (July 18, 1988)

FDA data resources