Device Classification Name |
acid phosphatase, naphthyl phosphate
|
510(k) Number |
K981743 |
Device Name |
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER |
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 | 862.1020
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/18/1998 |
Decision Date | 06/09/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|