Device Classification Name |
System, Test, Radioallergosorbent (Rast) Immunological
|
510(k) Number |
K051677 |
Device Name |
OPTIGEN ALLERGEN SPECIFIC IGE ASSAY |
Applicant |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
630 CLYDE CT. |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
EMI ZYCHLINSKY |
Correspondent |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
630 CLYDE CT. |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
EMI ZYCHLINSKY |
Regulation Number | 866.5750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/21/2005 |
Decision Date | 01/23/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|