Device Classification Name |
discs, strips and reagents, microorganism differentiation
|
510(k) Number |
K820209 |
Device Name |
ZYME B |
Applicant |
DMS LABORATORIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
DMS LABORATORIES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 866.2660
|
Classification Product Code |
|
Date Received | 01/26/1982 |
Decision Date | 02/12/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|