The following data is part of a premarket notification filed by Nanosphere, Inc with the FDA for Verigene C. Difficile Nucleic Acid Test (cdf).
| Device ID | K123197 |
| 510k Number | K123197 |
| Device Name: | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) |
| Classification | C. Difficile Toxin Gene Amplification Assay |
| 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 | OZN |
| CFR Regulation Number | 866.3130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-11 |
| Decision Date | 2012-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857573006362 | K123197 | 000 |
| 00857573006317 | K123197 | 000 |
| 00857573006256 | K123197 | 000 |
| 00857573006157 | K123197 | 000 |