Beckman Coulter, Inc. · Class II · Cleared May 17, 2000
| K-number | K000121 |
| Device name | IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB |
| Applicant | Beckman Coulter, Inc. |
| Product code | DFC |
| Device class | Class II |
| Decision date | May 17, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 866.5600 |
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