Antisera, Agglutinating, B. Pertussis, All
FDA product code GOY · Class I (low risk) · 21 CFR 866.3065 · Microbiology
1510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K781727 | Change in Sterilization ProcedureGOY · Traditional | Absorbent Cotton Co., Inc. | 12/04/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2920-2020 Class II | Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number:…Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM10) is not performing… | Remel Europe Ltd. | 07/23/2020Terminated |