Device Classification Name |
nad reduction/nadh oxidation, cpk or isoenzymes
|
510(k) Number |
K191296 |
Device Name |
Pointe Scientific Creatinine Kinase (CK) Reagent Set |
Applicant |
MedTest Dx |
5449 Research Drive |
Canton,
MI
48188
|
|
Applicant Contact |
William Cripps |
Correspondent |
MedTest Dx |
5449 Research Drive |
Canton,
MI
48188
|
|
Correspondent Contact |
William Cripps |
Regulation Number | 862.1215
|
Classification Product Code |
|
Date Received | 05/14/2019 |
Decision Date | 08/11/2020 |
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
|
|
|