The following data is part of a premarket notification filed by Nanosphere, Inc with the FDA for Verigene Cyp2c19 Nucleic Acid Tes (2c19).
| Device ID | K120466 |
| 510k Number | K120466 |
| Device Name: | VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) |
| Classification | Drug Metabolizing Enzyme Genotyping Systems |
| Applicant | NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Contact | Mark Del Vecchio |
| Correspondent | Mark Del Vecchio NANOSPHERE, INC 4088 COMMERCIAL AVENUE Northbrook, IL 60062 |
| Product Code | NTI |
| CFR Regulation Number | 862.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-15 |
| Decision Date | 2012-11-06 |
| Summary: | summary |