Device Classification Name |
ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
|
510(k) Number |
K963213 |
Device Name |
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL |
Applicant |
BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. |
P.O. BOX 50457 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Applicant Contact |
JOHN D STEVENS |
Correspondent |
BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. |
P.O. BOX 50457 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Correspondent Contact |
JOHN D STEVENS |
Regulation Number | 862.1475
|
Classification Product Code |
|
Date Received | 08/16/1996 |
Decision Date | 10/23/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|