Device Classification Name |
atp and creatine kinase (enzymatic), creatine |
|||
---|---|---|---|---|
510(k) Number | K992140 | |||
Device Name | PICCOLO METLYTE 7 REAGENT DISC | |||
Applicant |
|
|||
Applicant Contact | lisa mcgrath | |||
Correspondent |
|
|||
Correspodent Contact | lisa mcgrath | |||
Regulation Number | 862.1210 | |||
Classification Product Code |
|
|||
Subsequent Product Codes |
|
|||
Date Received | 06/24/1999 | |||
Decision Date | 08/26/1999 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
Clinical Chemistry |
|||
510k Review Panel |
Clinical Chemistry |
|||
summary |
summary |
|||
CLIA Waiver | CLIA Waiver Decision Summary | |||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |
|||
Recalls | CDRH Recalls |