K042335 is an FDA 510(k) clearance for the ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05. 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 September 17, 2004, 18 days after receiving the submission on August 30, 2004.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K042335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2004 |
| Decision Date | September 17, 2004 |
| Days to Decision | 18 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 |