Device Classification Name |
Colorimeter, Photometer, Spectrophotometer For Clinical Use
|
510(k) Number |
K822720 |
Device Name |
MODEL 340 SPECTROPHOTOMETER |
Applicant |
ABBOTT DIAGNOSTICS |
850 MAUDE AVE. |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent |
ABBOTT DIAGNOSTICS |
850 MAUDE AVE. |
MOUNTAIN VIEW,
CA
94043
|
|
Regulation Number | 862.2300
|
Classification Product Code |
|
Date Received | 09/07/1982 |
Decision Date | 10/08/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|