Device Classification Name |
system, test, vitamin d
|
510(k) Number |
K142351 |
Device Name |
25-Hydroxy Vitamin Ds EIA |
Applicant |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
10 DIDCOT WAY, |
BOLDEN BUSINESS PARK |
BOLDON, TYNE & WEAR,
GB
NE35 9PD
|
|
Applicant Contact |
Mick Henderson |
Correspondent |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
10 DIDCOT WAY, |
BOLDEN BUSINESS PARK |
BOLDON, TYNE & WEAR,
GB
NE35 9PD
|
|
Correspondent Contact |
Mick Henderson |
Regulation Number | 862.1825
|
Classification Product Code |
|
Date Received | 08/22/2014 |
Decision Date | 08/25/2015 |
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
|
|
|