Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K200349 |
Device Name |
Stat Profile Prime Plus Analyzer System |
Applicant |
Nova Biomedical Corporation |
200 Prospect Street |
Waltham,
MA
02454
|
|
Applicant Contact |
Rachel Gilbert |
Correspondent |
Nova Biomedical Corporation |
200 Prospect Street |
Waltham,
MA
02454
|
|
Correspondent Contact |
Rachel Gilbert |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/12/2020 |
Decision Date | 03/13/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|