The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Stat Profile Prime Plus Analyzer System.
Device ID | K180340 |
510k Number | K180340 |
Device Name: | Stat Profile Prime Plus Analyzer System |
Classification | Glucose Oxidase, Glucose |
Applicant | Nova Biomedical Corporation 200 Prospect St. Waltham, MA 02454 |
Contact | Adam Heroux |
Correspondent | Cesidio Tempesta Nova Biomedical Corporation 200 Prospect St. Waltham, MA 02454 |
Product Code | CGA |
Subsequent Product Code | CDS |
Subsequent Product Code | CGL |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-02-07 |
Decision Date | 2018-09-26 |
Summary: | summary |