Device Classification Name |
single (specified) analyte controls (assayed and unassayed)
|
510(k) Number |
K060481 |
Device Name |
LIBERTY GLUCOSE CONTROL SOLUTION |
Applicant |
LIBERTY HEALTHCARE GROUP, INC. |
940 CROSSROADS BLVD. |
SEGUIN,
TX
78155
|
|
Applicant Contact |
JOHN C GORMLEY |
Correspondent |
LIBERTY HEALTHCARE GROUP, INC. |
940 CROSSROADS BLVD. |
SEGUIN,
TX
78155
|
|
Correspondent Contact |
JOHN C GORMLEY |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 02/23/2006 |
Decision Date | 03/09/2006 |
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
|
|
|