Device Classification Name |
reagent/device, inoculum calibration
|
510(k) Number |
K820299 |
Device Name |
PROMPT INOCULATION SYSTEM |
Applicant |
3M COMPANY |
8124 PACIFIC AVE. |
WHITE CITY,
OR
97503
|
|
Correspondent |
3M COMPANY |
8124 PACIFIC AVE. |
WHITE CITY,
OR
97503
|
|
Regulation Number | 866.1640
|
Classification Product Code |
|
Date Received | 02/04/1982 |
Decision Date | 03/15/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|