K022041 is an FDA 510(k) clearance for the LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563. This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).
Submitted by Bio-Rad Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on July 16, 2002, 22 days after receiving the submission on June 24, 2002.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K022041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2002 |
| Decision Date | July 16, 2002 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |