Device Classification Name |
Urinary Homocystine (Nonquantitative) Test System
|
510(k) Number |
K121533 |
Device Name |
ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET |
Applicant |
Tosoh BioScience, Inc. |
6000 SHORELINE COURT |
SUITE 101 |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Applicant Contact |
ROBERT WICK |
Correspondent |
Tosoh BioScience, Inc. |
6000 SHORELINE COURT |
SUITE 101 |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Correspondent Contact |
ROBERT WICK |
Regulation Number | 862.1377
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/24/2012 |
Decision Date | 06/15/2012 |
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
|
|
|