Starch-Dye Bound Polymer, Amylase
FDA product code CIW · Class II (moderate risk) · 21 CFR 862.1070 · Clinical Chemistry
8510(k) clearances
0PMA approvals
5recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931559 | Dma Amylase ProcedureCIW · Traditional | Data Medical Associates, Inc. | 10/28/1993SE |
| K924339 | Olympus Amylase ReagentCIW · Traditional | Olympus Corp. | 10/19/1992SE |
| K884382 | Amylase Test (Amyl) Item Number: 65653CIW · Traditional | Em Diagnostic Systems, Inc. | 01/11/1989SE |
| K850639 | Enzymatic Alpha-Amylase Reagent KitCIW · Traditional | Bio-Analytics Laboratories, Inc. | 03/05/1985SE |
| K812027 | Kodak Ektachem Clin. Chem. Slides (Amyl)CIW · Traditional | Eastman Kodak Company | 08/03/1981SE |
| K810584 | Phadebas Isoamylase TestCIW · Traditional | Pharmacia, Inc. | 05/13/1981SE |
| K810669 | Pantrak E.K.CIW · Traditional | Calbiochem-Behring Corp. | 03/31/1981SE |
| K782032 | Unitest AmylaseCIW · Traditional | Boehringer Mannheim Corp. | 03/02/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2367-2020 Class II | VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI #…Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when… | Ortho-Clinical Diagnostics | 05/11/2020Terminated |
| Z-2366-2020 Class II | VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI #…Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when… | Ortho-Clinical Diagnostics | 05/11/2020Terminated |
| Z-2365-2020 Class II | VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code…Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when… | Ortho-Clinical Diagnostics | 05/11/2020Terminated |
| Z-2364-2020 Class II | VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code…Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when… | Ortho-Clinical Diagnostics | 05/11/2020Terminated |
| Z-0298-2014 Class II | VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |