Device Classification Name |
alcohol dehydrogenase, specific reagent for ethanol enzyme method
|
510(k) Number |
K032461 |
Device Name |
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 |
Applicant |
Lin-Zhi International, Inc. |
687 NORTH PASTORIA AVE. |
SUNNYVALE,
CA
94085 -2917
|
|
Applicant Contact |
CHENG I LIN |
Correspondent |
Lin-Zhi International, Inc. |
687 NORTH PASTORIA AVE. |
SUNNYVALE,
CA
94085 -2917
|
|
Correspondent Contact |
CHENG I LIN |
Regulation Number | 862.3040
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/11/2003 |
Decision Date | 10/03/2003 |
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
|
Recalls |
CDRH Recalls
|
|
|