HEMOCUE HEMOGLOBIN CALIBRATOR— 510(k) K882600

Substantially Equivalent

React and Co.

FDA 510(k) clearance K882600 for HEMOCUE HEMOGLOBIN CALIBRATOR, Substantially Equivalent on 1988-07-18. Applicant: React and Co.. Device class: 2.

Clearance details

Applicant: React and Co.
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 1988-06-24
Decision date: 1988-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manhattan Beach, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRZ

K052101 — C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C2005-08-26
K041130 — CDS HEMATOLOGY CALIBRATOR (CDS CAL)2004-06-10
K962864 — THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS1996-12-18
K951071 — ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS1995-07-24
K902892 — CELL-DYN CALIBRATOR1990-09-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.