Panels › Clinical Chemistry › Product code JHJ · Class 2
Agglutination Method, Human Chorionic Gonadotropin
Regulation 862.1155
0510(k)s in 12 months (96 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in JHJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Organon, Inc. | 11 | 0 |
| Armkel, LLC | 6 | 0 |
| Stanbio Laboratory | 4 | 0 |
| Cal-Tech Diagnostics, Inc. | 3 | 0 |
| Diagnostic Technology, Inc. | 3 | 0 |
| Immunostics Co., Inc. | 3 | 0 |
| Intl. Diagnostic, Inc. | 3 | 0 |
| Monoclonal Antibodies, Inc. | 3 | 0 |
| PerkinElmer Life and Analytical Sciences, Wallac, OY | 0 | 3 |
| Texas Immunology, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2019 | PerkinElmer Life and Analytical Sciences, Wallac, OY AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)
Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG). Open, Classified |
JHJ | K862044 |
| Jan 10, 2019 | PerkinElmer Life and Analytical Sciences, Wallac, OY AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)
Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG). Open, Classified |
JHJ | K862044 |
| Jan 10, 2019 | PerkinElmer Life and Analytical Sciences, Wallac, OY DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)
Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum. Open, Classified |
JHJ | K862044 |
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