Device Classification Name |
fluorescent proc. (qual.), galactose-1-phosphate uridyl transferase
|
510(k) Number |
K970277 |
Device Name |
URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) |
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 | 862.1315
|
Classification Product Code |
|
Date Received | 01/23/1997 |
Decision Date | 12/11/1997 |
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
|
Recalls |
CDRH Recalls
|
|
|