| Device Classification Name |
Colorimeter, Photometer, Spectrophotometer For Clinical Use
|
| 510(k) Number |
K881797 |
| Device Name |
EASY WASHER II MICROPLATE WASHER |
| Applicant |
| Slt Labinstruments, Inc. |
| 2110 Smithtown Ave. |
| Suite 3 |
|
Ronkonkoma,
NY
11779
|
|
| Applicant Contact |
DAVID L JURANAS |
| Correspondent |
| Slt Labinstruments, Inc. |
| 2110 Smithtown Ave. |
| Suite 3 |
|
Ronkonkoma,
NY
11779
|
|
| Correspondent Contact |
DAVID L JURANAS |
| Regulation Number | 862.2300 |
| Classification Product Code |
|
| Date Received | 04/27/1988 |
| Decision Date | 06/15/1988 |
| 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
|
|
|