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510(k) K011389

HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) by Canterbury Health Laboratories — Product Code JCM

K011389 is an FDA 510(k) premarket notification submitted by Canterbury Health Laboratories for the device "HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)". The FDA issued a decision of Substantially Equivalent on June 21, 2001. The device falls under product code JCM (Control, Hemoglobin, Abnormal), a Class II device regulated under 21 CFR 864.7415.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2001
Date Received
May 7, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Hemoglobin, Abnormal
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

Other clearances for product code JCM

  • K053031 — EXTENDSURE HBFASC CONTROL (December 7, 2005)
  • K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE (February 10, 1999)
  • K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (January 20, 1995)
  • K933086 — AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 (October 31, 1994)
  • K931234 — HEMOCARD CONTROL HB-AA, AE, FAA, FAE (May 11, 1993)
  • K924173 — HEMOCARD(TM) CONTROL (December 1, 1992)
  • K913427 — SICKLE HEMOGLOBIN (HBA/S) CONTROL SET (November 19, 1991)
  • K911347 — LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL (June 10, 1991)
  • K910431 — HEMOCARD CONTROL (March 11, 1991)
  • K820787 — HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL (April 8, 1982)

FDA data resources