K241800 is an FDA 510(k) clearance for the Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC). This device is classified as a System, Test, Low Density, Lipoprotein (Class I - General Controls, product code MRR).
Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on July 26, 2024, 35 days after receiving the submission on June 21, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K241800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2024 |
| Decision Date | July 26, 2024 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MRR — System, Test, Low Density, Lipoprotein |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |