Device Classification Name |
analyzer, chemistry (photometric, discrete), for clinical use
|
510(k) Number |
K943493 |
Device Name |
DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
Applicant |
HAMILTON CO. |
3371 LENORA CHURCH OD |
SNELLVILLE,
GA
30278
|
|
Applicant Contact |
TIMOTHY COWART |
Correspondent |
HAMILTON CO. |
3371 LENORA CHURCH OD |
SNELLVILLE,
GA
30278
|
|
Correspondent Contact |
TIMOTHY COWART |
Regulation Number | 862.2160
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/19/1994 |
Decision Date | 01/30/1995 |
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
|
|
|