The following data is part of a premarket notification filed by Nanosphere, Inc with the FDA for Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, And Mthfr Nucleic Acid Test.
| Device ID | K070597 |
| 510k Number | K070597 |
| Device Name: | VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST |
| Classification | Instrumentation For Clinical Multiplex Test Systems |
| Applicant | NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Contact | Sue Kent |
| Correspondent | Sue Kent NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Product Code | NSU |
| Subsequent Product Code | NPQ |
| Subsequent Product Code | NPR |
| Subsequent Product Code | OMM |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-02 |
| Decision Date | 2007-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857573006393 | K070597 | 000 |
| 00857573006386 | K070597 | 000 |
| 00857573006348 | K070597 | 000 |
| 00857573006027 | K070597 | 000 |
| 00857573006003 | K070597 | 000 |