Formulations, Paraffin, All
Regulation 864.4010
0510(k)s in 12 months (11 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in KEO
| Company | 510(k)s | Recalls |
|---|---|---|
| Surgipath Medical Industries, Inc. | 3 | 0 |
| Abbott Molecular | 0 | 2 |
| American Scientific Products | 1 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 0 |
| Erie Scientific Co. | 1 | 0 |
| Miles Laboratories, Inc. | 1 | 0 |
| Richard-Allan Medical Ind., Inc. | 1 | 0 |
| Sakura Finetek USA Inc | 0 | 1 |
| Sherwood Medical Co. | 1 | 0 |
| Stephens Scientific | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2014 | Sakura Finetek USA Inc Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg.
for diagnostic chemistry use.
Sakura Finetek USA, Inc. Terminated |
KEO | None listed |
| Mar 16, 2010 | Abbott Molecular Paraffin Pretreatment Reagent Kit III; each kit contains the following:
5 x 50 mL Pretreatment Solution (1N sodium thiocyanate - NaSCN),
5 x 62.5 mL Protease Buffer III (50 mM Tris base, pH 8.0 5 mM Terminated |
KEO | None listed |
| Mar 16, 2010 | Abbott Molecular Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL Pretreatment Solution (sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer II (0.2N HCl), 5 x 250 mg Protease I (P Terminated |
KEO | None listed |
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