The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Factor Ii And Factor V Test.
| Device ID | K172913 |
| 510k Number | K172913 |
| Device Name: | Cobas Factor II And Factor V Test |
| Classification | Test, Factor Ii G20210a Mutations, Genomic Dna Pcr |
| Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Contact | Pooja Shah |
| Correspondent | Pooja Shah Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Product Code | NPR |
| CFR Regulation Number | 864.7280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-25 |
| Decision Date | 2018-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00875197005998 | K172913 | 000 |