Device Classification Name |
Urease, Photometric, Urea Nitrogen
|
510(k) Number |
K792328 |
Device Name |
STATTEK BUN |
Applicant |
BOEHRINGER MANNHEIM CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
BOEHRINGER MANNHEIM CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 11/19/1979 |
Decision Date | 12/18/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|