Device Classification Name |
system, test, radioallergosorbent (rast) immunological
|
510(k) Number |
K081217 |
Device Name |
HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM |
Applicant |
HYCOR BIOMEDICAL, INC. |
7272 CHAPMAN AVE. |
GARDEN GROVE,
CA
92841
|
|
Applicant Contact |
P. NARAYAN NAYAK |
Correspondent |
HYCOR BIOMEDICAL, INC. |
7272 CHAPMAN AVE. |
GARDEN GROVE,
CA
92841
|
|
Correspondent Contact |
P. NARAYAN NAYAK |
Regulation Number | 866.5750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/30/2008 |
Decision Date | 05/22/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|