Device Classification Name |
enzyme immunoassay, opiates
|
510(k) Number |
K050733 |
Device Name |
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS |
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 | 862.3650
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/17/2005 |
Decision Date | 06/13/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|