Beckman Coulter, Inc. · Class II · Cleared Sep 24, 1998
| K-number | K981985 |
| Device name | ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 |
| Applicant | Beckman Coulter, Inc. |
| Product code | DHX |
| Device class | Class II |
| Decision date | Sep 24, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 866.6010 |
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