Device Classification Name |
Immunoassay Method, Troponin Subunit
|
510(k) Number |
K031739 |
Device Name |
I-STAT CARDIAC TROPONIN (CTNI) TEST |
Applicant |
I-STAT CORPORATION |
104 WINDSOR CENTER DR. |
EAST WINDSOR,
NJ
08520
|
|
Applicant Contact |
GREGORY W SHIPP |
Correspondent |
I-STAT CORPORATION |
104 WINDSOR CENTER DR. |
EAST WINDSOR,
NJ
08520
|
|
Correspondent Contact |
GREGORY W SHIPP |
Regulation Number | 862.1215
|
Classification Product Code |
|
Date Received | 06/04/2003 |
Decision Date | 09/02/2003 |
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
|
|
|