JCM — Control, Hemoglobin, Abnormal Class II
FDA product code JCM covers "Control, Hemoglobin, Abnormal", a Class II medical device regulated under 21 CFR 864.7415. Submissions are reviewed by the Hematology panel. At least 12 recent 510(k) clearances have been granted under this product code.
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 |