Product code JCM— Hematology
AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
- Classification name
- Control, Hemoglobin, Abnormal
- Device class
- Class 2
- Regulation
- 21 CFR 864.7415
- Advisory panel
- Hematology
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code JCM
FDA has cleared devices under product code JCM between 1982 and 2005, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2005
- 2001
- 1999
- 1995
- 1994
- 1993
- 1992
- 1991
- 1982
Top applicants under product code JCM
Recent clearances under product code JCM
- K053031 — EXTENDSURE HBFASC CONTROL
- K011389 — HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
- K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
- K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS
- K933086 — AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
- K931234 — HEMOCARD CONTROL HB-AA, AE, FAA, FAE
- K924173 — HEMOCARD(TM) CONTROL
- K913427 — SICKLE HEMOGLOBIN (HBA/S) CONTROL SET
- K911347 — LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
- K910431 — HEMOCARD CONTROL
- K820787 — HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL
- K820037 — SICKLE-CHECK
Data sourced from openFDA. This site is unofficial and independent of the FDA.