Panels › Clinical Chemistry › Product code JHN · Class 1
Turbidimetric Method, Lipoproteins
Regulation 862.1475
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in JHN
| Company | 510(k)s | Recalls |
|---|---|---|
| Olympus America, Inc. | 2 | 0 |
| Randox Laboratories, Ltd. | 2 | 0 |
| Sigma Diagnostics, Inc. | 2 | 0 |
| Beckman Coulter Ireland, Inc. | 0 | 1 |
| Wako Chemicals USA, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2025 | Beckman Coulter Ireland, Inc. Apo B Reagent, REF: OSR6143 Open, Classified |
JHN | K952466 |
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