Beckman Coulter, Inc. · Class II · Cleared Oct 16, 2009
| K-number | K091846 |
| Device name | SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 |
| Applicant | Beckman Coulter, Inc. |
| Product code | JFJ |
| Device class | Class II |
| Decision date | Oct 16, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 862.1070 |
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