Device Classification Name |
Immunoassay Method, Troponin Subunit
|
510(k) Number |
K981882 |
Device Name |
CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST |
Applicant |
PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 |
MONMOUTH JUNCTION,
NJ
08852 -1905
|
|
Applicant Contact |
JEMO KANG |
Correspondent |
PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 |
MONMOUTH JUNCTION,
NJ
08852 -1905
|
|
Correspondent Contact |
JEMO KANG |
Regulation Number | 862.1215
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/28/1998 |
Decision Date | 07/06/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|