Device Classification Name |
enzymatic method, creatinine
|
510(k) Number |
K070383 |
Device Name |
ENZYMATIC CREATININE ASSAY (265 SERIES) |
Applicant |
DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. |
CHARLOTTETOWN, P.E.I.,
CA
C1E 2A6
|
|
Applicant Contact |
DEBBIE M MURRAY |
Correspondent |
DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. |
CHARLOTTETOWN, P.E.I.,
CA
C1E 2A6
|
|
Correspondent Contact |
DEBBIE M MURRAY |
Regulation Number | 862.1225
|
Classification Product Code |
|
Date Received | 02/09/2007 |
Decision Date | 06/22/2007 |
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
|
Recalls |
CDRH Recalls
|
|
|