JCM — Control, Hemoglobin, Abnormal Class II
FDA Device Classification
Classification Details
- Product Code
- JCM
- Device Class
- Class II
- Regulation Number
- 864.7415
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K053031 | cantebury scientific | EXTENDSURE HBFASC CONTROL | December 7, 2005 |
| K011389 | canterbury health laboratories | HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) | June 21, 2001 |
| K983704 | roche diagnostic systems | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | February 10, 1999 |
| K942222 | isolab | QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS | January 20, 1995 |
| K933086 | helena laboratories | AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 | October 31, 1994 |
| K931234 | isolab | HEMOCARD CONTROL HB-AA, AE, FAA, FAE | May 11, 1993 |
| K924173 | isolab | HEMOCARD(TM) CONTROL | December 1, 1992 |
| K913427 | creative laboratory products | SICKLE HEMOGLOBIN (HBA/S) CONTROL SET | November 19, 1991 |
| K911347 | bio-rad | LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL | June 10, 1991 |
| K910431 | isolab | HEMOCARD CONTROL | March 11, 1991 |
| K820787 | helena laboratories | HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL | April 8, 1982 |
| K820037 | diagnostic technology | SICKLE-CHECK | February 4, 1982 |