The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Architect Free Psa Mastercheck, Model 6c07-05; Architect Tital Psa Mastercheck, Model 6c06-05.
| Device ID | K042335 |
| 510k Number | K042335 |
| Device Name: | ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Maria Zeballos |
| Correspondent | Maria Zeballos BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-30 |
| Decision Date | 2004-09-17 |
| Summary: | summary |