Beckman Coulter, Inc. · Class I · Cleared Aug 22, 2000
| K-number | K001935 |
| Device name | ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 |
| Applicant | Beckman Coulter, Inc. |
| Product code | CDZ |
| Device class | Class I |
| Decision date | Aug 22, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 862.1680 |
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