Device Classification Name |
analyzer, chemistry (photometric, discrete), for clinical use
|
510(k) Number |
K921661 |
Device Name |
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER |
Applicant |
BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250 -0457
|
|
Applicant Contact |
JOHN STEVENS |
Correspondent |
BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250 -0457
|
|
Correspondent Contact |
JOHN STEVENS |
Regulation Number | 862.2160
|
Classification Product Code |
|
Date Received | 04/07/1992 |
Decision Date | 06/30/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|