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 |