Panels › Hematology › Product code JBD · Class 2
System, Analysis, Electrophoretic Hemoglobin
Regulation 864.7440
0510(k)s in 12 months (26 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in JBD
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 11 | 1 |
| Corning Medical & Scientific | 3 | 0 |
| Beckman Instruments, Inc. | 2 | 0 |
| Electrophoresis Corp. of America | 2 | 0 |
| Gelman Sciences, Inc. | 2 | 0 |
| Interlab S.R.L. | 2 | 0 |
| Isolab, Inc. | 2 | 0 |
| Miles Laboratories, Inc. | 1 | 0 |
| Morax | 1 | 0 |
| PerkinElmer LAS Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2018 | Helena Laboratories, Corp. SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415,
for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems Open, Classified |
JBD | K982426 |
| Oct 25, 2006 | Sebia, Inc. HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France Terminated |
JBD | K991362 |
| Jul 23, 2004 | PerkinElmer LAS Inc RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use. Terminated |
JBD | K840011 |
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