HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)— 510(k) K011389

Name: FDA 510(k) clearance K011389
Creator: U.S. Food and Drug Administration
Published: 2001-06-21

Substantially Equivalent

Canterbury Health Laboratories

FDA 510(k) clearance K011389 for HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL), Substantially Equivalent on 2001-06-21. Applicant: Canterbury Health Laboratories. Device class: 2.

Clearance details

Applicant: Canterbury Health Laboratories
Product code: Code JCM
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 2001-05-07
Decision date: 2001-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Christchurch, Canterbury, NZ

Download summary PDF View on FDA.gov ↗

Recent devices under product code JCM

view all

K053031 — EXTENDSURE HBFASC CONTROL2005-12-07
K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE1999-02-10
K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS1995-01-20
K933086 — AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #53281994-10-31
K931234 — HEMOCARD CONTROL HB-AA, AE, FAA, FAE1993-05-11

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