Device Classification Name |
radioimmunoassay, testosterones and dihydrotestosterone
|
510(k) Number |
K052649 |
Device Name |
DRG SLV TESTOSTERONE ELISA TEST |
Applicant |
DRG INTL., INC. |
150 CHERRY LANE RD. |
EAST STROUDSBURG,
PA
18301
|
|
Applicant Contact |
Gary Lehnus |
Correspondent |
DRG INTL., INC. |
150 CHERRY LANE RD. |
EAST STROUDSBURG,
PA
18301
|
|
Correspondent Contact |
Gary Lehnus |
Regulation Number | 862.1680
|
Classification Product Code |
|
Date Received | 09/26/2005 |
Decision Date | 01/27/2006 |
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
|
|
|