Device Classification Name |
system, test, human chorionic gonadotropin
|
510(k) Number |
K063720 |
Device Name |
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS |
Applicant |
ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14626 -5101
|
|
Applicant Contact |
SARAH CV PARSONS |
Correspondent |
ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14626 -5101
|
|
Correspondent Contact |
SARAH CV PARSONS |
Regulation Number | 862.1155
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/15/2006 |
Decision Date | 04/09/2007 |
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
|
|
|