Device Classification Name |
Urease, Photometric, Urea Nitrogen
|
510(k) Number |
K943042 |
Device Name |
BUN QVET |
Applicant |
PRISMA SYSTEMS |
1721 BLACK RIVER BLVD. |
ROME,
NY
13440
|
|
Applicant Contact |
LARRY BEASLEY |
Correspondent |
PRISMA SYSTEMS |
1721 BLACK RIVER BLVD. |
ROME,
NY
13440
|
|
Correspondent Contact |
LARRY BEASLEY |
Regulation Number | 862.1770
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/27/1994 |
Decision Date | 12/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|