Device Classification Name |
Immunoassay Method, Troponin Subunit
|
510(k) Number |
K070640 |
Device Name |
ARCHITECT STAT TROPONIN-1; MYOGLOBIN |
Applicant |
FISHER DIAGNOSTICS |
8365 VALLEY PIKE, PO BX 307 |
MIDDLETOWN,
VA
22645
|
|
Applicant Contact |
HEATHER CAMERON |
Correspondent |
FISHER DIAGNOSTICS |
8365 VALLEY PIKE, PO BX 307 |
MIDDLETOWN,
VA
22645
|
|
Correspondent Contact |
HEATHER CAMERON |
Regulation Number | 862.1215
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/07/2007 |
Decision Date | 09/13/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|