Device Classification Name |
Automated Urinalysis System
|
510(k) Number |
K053253 |
Device Name |
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM |
Applicant |
HEMOCUE AB |
40 EMPIRE DRIVE |
LAKE FOREST,
CA
92630
|
|
Applicant Contact |
ALLAN WHITE |
Correspondent |
HEMOCUE AB |
40 EMPIRE DRIVE |
LAKE FOREST,
CA
92630
|
|
Correspondent Contact |
ALLAN WHITE |
Regulation Number | 862.2900
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/21/2005 |
Decision Date | 02/17/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|