K964064 is an FDA 510(k) clearance for the RDI LIPIDIRECT MAGNETIC LDL REAGENT. This device is classified as a System, Test, Low Density, Lipoprotein (Class I - General Controls, product code MRR).
Submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on November 20, 1996, 41 days after receiving the submission on October 10, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K964064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 1996 |
| Decision Date | November 20, 1996 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | MRR — System, Test, Low Density, Lipoprotein |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |