Panels › Immunology › Product code CFF · Class 2
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Regulation 866.5510
0510(k)s in 12 months (29 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in CFF
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 6 | 2 |
| Sebia | 8 | 0 |
| Kamiya Biomedical Co. | 2 | 1 |
| Morax | 3 | 0 |
| Beckman Coulter, Inc. | 1 | 1 |
| The Binding Site, Ltd. | 2 | 0 |
| Grifols | 2 | 0 |
| Beckman Instruments, Inc. | 1 | 0 |
| Corning Medical & Scientific | 1 | 0 |
| Crestat Diagnostics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2022 | Kamiya Biomedical Company, LLC K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013 Open, Classified |
CFF | K993213 |
| Apr 6, 2022 | Helena Laboratories, Corp. V8 Immunodisplacement Kit REF 1803 Open, Classified |
CFF | K111369 |
| Jul 21, 2017 | Helena Laboratories, Corp. SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. Terminated |
CFF | K973040 |
| Jul 23, 2004 | Beckman Coulter Inc IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit.
Part Numbers:
446360 (250 test kit)
446260 (50 Terminated |
CFF | None listed |
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