Device Classification Name |
1-nitroso-2-naphthol (fluorometric), free tyrosine
|
510(k) Number |
K970093 |
Device Name |
TYROSINE 50-HOUR REAGENT KIT |
Applicant |
ASTORIA-PACIFIC,INC. |
14600 S.E. 82ND DR. |
CLACKAMAS,
OR
97015 -0830
|
|
Applicant Contact |
RAYMOND L PAVITT |
Correspondent |
ASTORIA-PACIFIC,INC. |
14600 S.E. 82ND DR. |
CLACKAMAS,
OR
97015 -0830
|
|
Correspondent Contact |
RAYMOND L PAVITT |
Regulation Number | 862.1730
|
Classification Product Code |
|
Date Received | 01/10/1997 |
Decision Date | 03/19/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|