Device Classification Name |
urease and glutamic dehydrogenase, urea nitrogen
|
510(k) Number |
K870571 |
Device Name |
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 |
Applicant |
EM DIAGNOSTIC SYSTEMS, INC. |
480 DEMOCRAT RD. |
GIBBSTOWN,
NJ
08027
|
|
Applicant Contact |
RAYMOND L MILLER |
Correspondent |
EM DIAGNOSTIC SYSTEMS, INC. |
480 DEMOCRAT RD. |
GIBBSTOWN,
NJ
08027
|
|
Correspondent Contact |
RAYMOND L MILLER |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 02/10/1987 |
Decision Date | 03/04/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|