The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Roche Amplichip Cyp450 Test.
| Device ID | K043576 |
| 510k Number | K043576 |
| Device Name: | ROCHE AMPLICHIP CYP450 TEST |
| Classification | Drug Metabolizing Enzyme Genotyping Systems |
| Applicant | ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton, CA 94588 -2722 |
| Contact | James F Kelly |
| Correspondent | James F Kelly ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE Pleasanton, CA 94588 -2722 |
| Product Code | NTI |
| CFR Regulation Number | 862.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-27 |
| Decision Date | 2005-01-10 |
| Summary: | summary |