The following data is part of a premarket notification filed by Autogenomics, Incorporated with the FDA for Infiniti Cyp2c19 Assay.
| Device ID | K101683 |
| 510k Number | K101683 |
| Device Name: | INFINITI CYP2C19 ASSAY |
| Classification | Drug Metabolizing Enzyme Genotyping Systems |
| Applicant | AUTOGENOMICS, INCORPORATED 2980 SCOTT STREET Vista, CA 92081 |
| Contact | Evelyn G Lopez |
| Correspondent | Evelyn G Lopez AUTOGENOMICS, INCORPORATED 2980 SCOTT STREET Vista, CA 92081 |
| Product Code | NTI |
| CFR Regulation Number | 862.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-15 |
| Decision Date | 2010-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850009370150 | K101683 | 000 |
| 00850009370143 | K101683 | 000 |
| 00850009370136 | K101683 | 000 |