The following data is part of a premarket notification filed by Autogenomics, Inc with the FDA for Infiniti System.
| Device ID | K060564 |
| 510k Number | K060564 |
| Device Name: | INFINITI SYSTEM |
| Classification | Test, Factor V Leiden Mutations, Genomic Dna Pcr |
| Applicant | AUTOGENOMICS, INC 2251 RUTHERFORD ROAD Carlsbad, CA 92008 |
| Contact | Evelyn Lopez |
| Correspondent | Evelyn Lopez AUTOGENOMICS, INC 2251 RUTHERFORD ROAD Carlsbad, CA 92008 |
| Product Code | NPQ |
| Subsequent Product Code | NPR |
| Subsequent Product Code | NSU |
| CFR Regulation Number | 864.7280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-03 |
| Decision Date | 2007-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850009370129 | K060564 | 000 |
| 00850009370112 | K060564 | 000 |
| 00850009370105 | K060564 | 000 |
| 00850009370099 | K060564 | 000 |
| 00850009370082 | K060564 | 000 |
| 00850009370075 | K060564 | 000 |
| 00850009370068 | K060564 | 000 |
| 00850009370051 | K060564 | 000 |
| 00850009370044 | K060564 | 000 |