Device Classification Name |
system, test, immunological, antigen, tumor
|
510(k) Number |
K971418 |
FOIA Releasable 510(k) |
K971418
|
Device Name |
CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER |
Applicant |
CHIRON DIAGNOSTICS CORP. |
63 NORTH ST. |
MEDFIELD,
MA
02052
|
|
Applicant Contact |
William J Pignato |
Correspondent |
CHIRON DIAGNOSTICS CORP. |
63 NORTH ST. |
MEDFIELD,
MA
02052
|
|
Correspondent Contact |
William J Pignato |
Regulation Number | 866.6010
|
Classification Product Code |
|
Date Received | 04/16/1997 |
Decision Date | 07/17/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|