Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K062319 |
Device Name |
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360 |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD |
P.O. BOX 50457 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Applicant Contact |
CORINA HARPER |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD |
P.O. BOX 50457 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Correspondent Contact |
CORINA HARPER |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 08/09/2006 |
Decision Date | 09/13/2006 |
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
|
|
|