K000121 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB. This device is classified as a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II - Special Controls, product code DFC).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on May 17, 2000, 120 days after receiving the submission on January 18, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5600.
| 510(k) Number | K000121 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2000 |
| Decision Date | May 17, 2000 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DFC — Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5600 |