Bionostics, Inc. · Class I · Cleared Feb 25, 2005
| K-number | K050100 |
| Device name | RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER |
| Applicant | Bionostics, Inc. |
| Product code | JJX |
| Device class | Class I |
| Decision date | Feb 25, 2005 |
| Decision | Substantially Equivalent |
| Regulation | 862.1660 |
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