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510(k) K831306

HEMACAL by Hematology Marketing Assoc. — Product Code KRZ

K831306 is an FDA 510(k) premarket notification submitted by Hematology Marketing Assoc. for the device "HEMACAL". The FDA issued a decision of Substantially Equivalent on June 16, 1983. The device falls under product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement), a Class II device regulated under 21 CFR 864.8165. Hematology Marketing Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1983
Date Received
April 22, 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 Hematology Marketing Assoc.

  • K851843 — OSMOCEL 3 (July 30, 1985)
  • K851375 — TRI-COUNT (July 12, 1985)
  • K850094 — LASER-GLOBIN POWDER (March 29, 1985)
  • K850095 — LASER-DIL (March 29, 1985)
  • K850097 — LASER-LYSE (March 29, 1985)
  • K850096 — LASER-GLOBIN (March 29, 1985)
  • K844708 — TRI-COUNT CALIBRATOR (March 5, 1985)
  • K843485 — TRI-COUNT LASER (December 12, 1984)
  • K834371 — TRI-COUNT 10 (March 9, 1984)
  • K833130 — TRI-COUNT 7 (October 20, 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)
  • K883703 — MSI-CAL 7 (November 22, 1988)
  • K883850 — MSI-CAL 16 (November 22, 1988)
  • K883851 — MSI-CAL 8 (November 22, 1988)

FDA data resources