Device Classification Name |
osmometer for clinical use
|
510(k) Number |
K834208 |
Device Name |
COLLOID OSMOMETER 4400 |
Applicant |
WESCOR, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
WESCOR, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.2730
|
Classification Product Code |
|
Date Received | 12/05/1983 |
Decision Date | 03/23/1984 |
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
|
|
|