Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K981305 |
Device Name |
OLYMPUS SERUM PROTEIN MULTICALIBRATOR |
Applicant |
OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Applicant Contact |
LAURA STORMS-TYLER |
Correspondent |
OLYMPUS AMERICA, INC. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Correspondent Contact |
LAURA STORMS-TYLER |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 04/10/1998 |
Decision Date | 05/07/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|