The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Hemosil Factor Ii & Factor V Assay.
| Device ID | K082118 |
| 510k Number | K082118 |
| Device Name: | XPERT HEMOSIL FACTOR II & FACTOR V ASSAY |
| Classification | Test, Factor V Leiden Mutations, Genomic Dna Pcr |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Contact | Russel K Enns |
| Correspondent | Russel K Enns CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Product Code | NPQ |
| Subsequent Product Code | NPR |
| Subsequent Product Code | OOI |
| CFR Regulation Number | 864.7280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-28 |
| Decision Date | 2009-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940000936 | K082118 | 000 |
| 07332940000240 | K082118 | 000 |