Bayer Corp. · Class I · Cleared Sep 27, 1996
| K-number | K963080 |
| Device name | TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) |
| Applicant | Bayer Corp. |
| Product code | CDZ |
| Device class | Class I |
| Decision date | Sep 27, 1996 |
| Decision | Substantially Equivalent |
| Regulation | 862.1680 |
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