Control, Hemoglobin, Abnormal
An abnormal hemoglobin control is a reference material used in hematology laboratories to verify the accuracy and reproducibility of hemoglobin analysis systems when detecting variant hemoglobin types associated with disorders such as sickle cell disease. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JCM, regulated under 21 CFR 864.7415, within the Hematology medical specialty. No special flags apply to this device.
Research product code JCM in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- JCM
- Device Class
- FDA class 2
- Regulation Number
- 864.7415
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K053031 | EXTENDSURE HBFASC CONTROL | Dec 07, 2005 | Substantially Equivalent | Cantebury Scientific , Ltd. |
| K011389 | HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) | Jun 21, 2001 | Substantially Equivalent | Canterbury Health Laboratories |
| K983704 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | Feb 10, 1999 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K942222 | QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS | Jan 20, 1995 | Substantially Equivalent | Isolab, Inc. |
| K933086 | AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 | Oct 31, 1994 | Substantially Equivalent | Helena Laboratories |
| K931234 | HEMOCARD CONTROL HB-AA, AE, FAA, FAE | May 11, 1993 | Substantially Equivalent | Isolab, Inc. |
| K924173 | HEMOCARD(TM) CONTROL | Dec 01, 1992 | Substantially Equivalent | Isolab, Inc. |
| K913427 | SICKLE HEMOGLOBIN (HBA/S) CONTROL SET | Nov 19, 1991 | Substantially Equivalent | Creative Laboratory Products, Inc. |
| K911347 | LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL | Jun 10, 1991 | Substantially Equivalent | Bio-Rad |
| K910431 | HEMOCARD CONTROL | Mar 11, 1991 | Substantially Equivalent | Isolab, Inc. |
| K820787 | HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL | Apr 08, 1982 | Substantially Equivalent | Helena Laboratories |
| K820037 | SICKLE-CHECK | Feb 04, 1982 | Substantially Equivalent | Diagnostic Technology, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.