Device Classification Name |
electrode, ion specific, urea nitrogen
|
510(k) Number |
K860543 |
Device Name |
BLOOD UREA NITROGEN (BUN) TESTCARD |
Applicant |
ILEX CORP. |
C/O MEDICAL DEVICE CONSULTANTS |
45 WEST STREET, SUITE 2 |
ATTLEBORO,
MA
02703
|
|
Applicant Contact |
WILLIAM A MORTON |
Correspondent |
ILEX CORP. |
C/O MEDICAL DEVICE CONSULTANTS |
45 WEST STREET, SUITE 2 |
ATTLEBORO,
MA
02703
|
|
Correspondent Contact |
WILLIAM A MORTON |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 02/13/1986 |
Decision Date | 04/21/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|