Beckman Coulter, Inc. · Class I · Cleared Aug 27, 2009
| K-number | K083867 |
| Device name | ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND |
| Applicant | Beckman Coulter, Inc. |
| Product code | CDZ |
| Device class | Class I |
| Decision date | Aug 27, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 862.1680 |
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