Panels › Immunology › Product code LKP · Class 2
Anti-Sm Antibody, Antigen And Control
Regulation 866.5100
0510(k)s in 12 months (28 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LKP
| Company | 510(k)s | Recalls |
|---|---|---|
| Phadia AB | 2 | 1 |
| Bio-Rad | 2 | 0 |
| General Biometrics, Inc. | 2 | 0 |
| Lipogen, Inc. | 2 | 0 |
| Quest Intl., Inc. | 2 | 0 |
| Shield Diagnostics, Ltd. | 2 | 0 |
| American Bionetics, Inc. | 1 | 0 |
| Cogent Diagnotics , Ltd. | 1 | 0 |
| Diagnostic Chemicals, Ltd. (Usa) | 1 | 0 |
| Elias U.S.A., Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2016 | Phadia Ab EliA SmDP Well, Article Number 14-5624-01
Product Usage:
EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate Terminated |
LKP | K132631 |
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