| Device Classification Name |
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
|
|---|
| 510(k) Number |
K014018 |
|---|
| Device Name |
CHOLESTEROL 1, 2, 3 |
|---|
| Applicant |
| IMI |
| 16809 BRIARDALE RD. |
|
ROCKVILLE,
MD
20855
|
|
| Applicant Contact |
THOMAS M TSAKERIS |
| Correspondent |
| IMI |
| 16809 BRIARDALE RD. |
|
ROCKVILLE,
MD
20855
|
|
| Correspondent Contact |
THOMAS M TSAKERIS |
| Regulation Number | 862.1475 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 12/06/2001 |
|---|
| Decision Date | 06/24/2002 |
|---|
| Decision |
SE - With Limitations
(SESU) |
|---|
| Regulation Medical Specialty |
Clinical Chemistry
|
|---|
| 510k Review Panel |
Clinical Chemistry
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|