Product code JBD— Hematology
REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
- Classification name
- System, Analysis, Electrophoretic Hemoglobin
- Device class
- Class 2
- Regulation
- 21 CFR 864.7440
- Advisory panel
- Hematology
- Total cleared
- 26
- First cleared
- Most recent
Market context for product code JBD
FDA has cleared devices under product code JBD between 1977 and 2006, filed by 9 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
- 2006
- 2004
- 1999
- 1998
- 1993
- 1990
- 1983
- 1982
- 1981
- 1980
- 1979
- 1978
- 1977
Top applicants under product code JBD
Recent clearances under product code JBD
- K053571 — MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
- K032862 — INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
- K992199 — ACID HEMOGLOBIN KIT
- K991362 — HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
- K982426 — SPIFE ALKALINE HEMOGLOBIN
- K931503 — REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
- K931465 — REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
- K901143 — REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
- K830804 — LABILE REMOVING HEMOLYZING REAGENT
- K820518 — GELMAN GLYCO-PHORE BUFFER
- K813395 — CELLULOSE ACETATE-CITRATE AGAR HEMOGLO
- K810919 — HEMOGLOBIN ELECTROPHORESIS CONTROL
- K810047 — AUTOPHOR 128
- K802884 — CORNING NORMAL GLYCOSYLATED HEMOGLOBIN
- K802821 — PARAGON HEMOGLOBIN ELECTRO. REAG. KIT
- K800853 — A,SA2 LYOPHILIZED HEMO CONTROL
- K800854 — A,A2 LYOPHILIZED HEMO CONTROL
- K800855 — A,FSC LYOPHILIZED HEMO CONTROL
- K800856 — A,FDA2 LYOPHILIZED HEMO CONTROL
- K791008 — ECA (SPECIAL) HEME BUFFER
- K791290 — BECKMAN B-4 TEB BUFFER KIT
- K790944 — CITRATE AGAR GEL AND BUFFER SET
- K781119 — ECA HEME BUFFER
- K780807 — HBF-QUIPLATE METHODOLOGY
- K780163 — REDI-DISC HEMOGLOBIN GEL TUBE KIT
- K771649 — HEMOGLOBIN A2 TESTING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.