Device Classification Name |
enzyme controls (assayed and unassayed)
|
510(k) Number |
K950803 |
Device Name |
ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE |
Applicant |
ISOLAB, INC. |
DRAWER 4350 |
AKRON,
OH
44321
|
|
Applicant Contact |
JANET PERKINS |
Correspondent |
ISOLAB, INC. |
DRAWER 4350 |
AKRON,
OH
44321
|
|
Correspondent Contact |
JANET PERKINS |
Regulation Number | 862.1660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/21/1995 |
Decision Date | 09/21/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|