Device Classification Name |
alcohol dehydrogenase, specific reagent for ethanol enzyme method
|
510(k) Number |
K121256 |
Device Name |
ALCO-SCREEN 02 |
Applicant |
CHEMATICS, INC. |
P.O. BOX 293 |
HIGHWAY 13 SOUTH |
NORTH WEBSTER,
IN
46555
|
|
Applicant Contact |
CARL REYNOLDS |
Correspondent |
CHEMATICS, INC. |
P.O. BOX 293 |
HIGHWAY 13 SOUTH |
NORTH WEBSTER,
IN
46555
|
|
Correspondent Contact |
CARL REYNOLDS |
Regulation Number | 862.3040
|
Classification Product Code |
|
Date Received | 04/25/2012 |
Decision Date | 09/12/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|