Device Classification Name |
enzymatic esterase--oxidase, cholesterol
|
510(k) Number |
K071593 |
Device Name |
PTS PANELS CHOL+HDL PANEL TEST STRIPS |
Applicant |
POLYMER TECHNOLOGY SYSTEMS, INC. |
7736 ZIONSVILLE RD. |
INDIANAPOLIS,
IN
46268
|
|
Applicant Contact |
MARGO ENRIGHT |
Correspondent |
POLYMER TECHNOLOGY SYSTEMS, INC. |
7736 ZIONSVILLE RD. |
INDIANAPOLIS,
IN
46268
|
|
Correspondent Contact |
MARGO ENRIGHT |
Regulation Number | 862.1175
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/11/2007 |
Decision Date | 10/15/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|