| Device Classification Name |
Stains, Chemical Solution
|
| 510(k) Number |
K840087 |
| Device Name |
PRESERV GOMORI TRICHROME STAIN 125/500 |
| Applicant |
| Preventive Diagnostics Corp. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Preventive Diagnostics Corp. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 864.1850 |
| Classification Product Code |
|
| Date Received | 01/10/1984 |
| Decision Date | 02/10/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Hematology
|
| 510k Review Panel |
Microbiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|