| Device Classification Name |
Colorimeter, Photometer, Spectrophotometer For Clinical Use
|
| 510(k) Number |
K801957 |
| Device Name |
MICRO-FLOW SPECTROPHOTOMETER CL-720 |
| Applicant |
| Shimadzu Precision Instruments, Inc. |
| 21010 S. Vermont Ave. |
|
Torrance,
CA
90502
|
|
| Correspondent |
| Shimadzu Precision Instruments, Inc. |
| 21010 S. Vermont Ave. |
|
Torrance,
CA
90502
|
|
| Regulation Number | 862.2300 |
| Classification Product Code |
|
| Date Received | 08/18/1980 |
| Decision Date | 09/26/1980 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Clinical Chemistry
|
| 510k Review Panel |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|