The following data is part of a premarket notification filed by Illumina, Inc. with the FDA for Illumina Verncode Genotyping Test For Facor V And Factor Ii.
| Device ID | K093129 |
| 510k Number | K093129 |
| Device Name: | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II |
| Classification | Test, Factor V Leiden Mutations, Genomic Dna Pcr |
| Applicant | ILLUMINA, INC. 9865 TOWNE CENTRE DRIVE San Diego, CA 92121 -1975 |
| Contact | Donald R Ellis |
| Correspondent | Donald R Ellis ILLUMINA, INC. 9865 TOWNE CENTRE DRIVE San Diego, CA 92121 -1975 |
| Product Code | NPQ |
| CFR Regulation Number | 864.7280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-02 |
| Decision Date | 2010-04-28 |