The following data is part of a premarket notification filed by Nanosphere, Inc with the FDA for Verigene Gram-positive Blood Culture (gc-gp) Nucleic Acid Test.
| Device ID | K122514 |
| 510k Number | K122514 |
| Device Name: | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST |
| Classification | Gram-positive Bacteria And Their Resistance Markers |
| 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 | PAM |
| CFR Regulation Number | 866.3365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-17 |
| Decision Date | 2012-09-19 |
| Summary: | summary |