JBD — System, Analysis, Electrophoretic Hemoglobin Class II
FDA product code JBD covers "System, Analysis, Electrophoretic Hemoglobin", a Class II medical device regulated under 21 CFR 864.7440. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JBD
- Device Class
- Class II
- Regulation Number
- 864.7440
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K053571 | interlab | MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOB | June 30, 2006 |
| K032862 | interlab | INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | February 3, 2004 |
| K992199 | helena laboratories | ACID HEMOGLOBIN KIT | September 21, 1999 |
| K991362 | morax | HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), A | June 21, 1999 |
| K982426 | helena laboratories | SPIFE ALKALINE HEMOGLOBIN | December 17, 1998 |
| K931503 | helena laboratories | REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) | August 16, 1993 |
| K931465 | helena laboratories | REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 | July 6, 1993 |
| K901143 | helena laboratories | REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) | May 23, 1990 |
| K830804 | corning medical and scientific | LABILE REMOVING HEMOLYZING REAGENT | May 4, 1983 |
| K820518 | gelman sciences | GELMAN GLYCO-PHORE BUFFER | April 9, 1982 |
| K813395 | helena laboratories | CELLULOSE ACETATE-CITRATE AGAR HEMOGLO | December 31, 1981 |
| K810919 | isolab | HEMOGLOBIN ELECTROPHORESIS CONTROL | April 23, 1981 |
| K810047 | gelman sciences | AUTOPHOR 128 | February 5, 1981 |
| K802884 | corning medical and scientific | CORNING NORMAL GLYCOSYLATED HEMOGLOBIN | December 22, 1980 |
| K802821 | beckman instruments | PARAGON HEMOGLOBIN ELECTRO. REAG. KIT | December 11, 1980 |
| K800856 | helena laboratories | A,FDA2 LYOPHILIZED HEMO CONTROL | April 29, 1980 |
| K800855 | helena laboratories | A,FSC LYOPHILIZED HEMO CONTROL | April 29, 1980 |
| K800853 | helena laboratories | A,SA2 LYOPHILIZED HEMO CONTROL | April 29, 1980 |
| K800854 | helena laboratories | A,A2 LYOPHILIZED HEMO CONTROL | April 29, 1980 |
| K791008 | electrophoresis corp. of america | ECA (SPECIAL) HEME BUFFER | August 3, 1979 |