K001118 is an FDA 510(k) clearance for the MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET. This device is classified as a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II - Special Controls, product code DFC).
Submitted by DiaSorin, Inc. (Ellicott City, US). The FDA issued a Cleared decision on April 25, 2000, 18 days after receiving the submission on April 7, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5600.
| 510(k) Number | K001118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2000 |
| Decision Date | April 25, 2000 |
| Days to Decision | 18 days |
| Submission Type | Special |
| 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 |