Device Classification Name |
Devices Detecting Influenza A, B, And C Virus Antigens
|
510(k) Number |
K982429 |
Device Name |
ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES |
Applicant |
ZYMETX, INC. |
800 RESEARCH PKWY., SUITE 100 |
OKLAHOMA CITY,
OK
73104
|
|
Applicant Contact |
CRAIG D SHIMASAKI |
Correspondent |
ZYMETX, INC. |
800 RESEARCH PKWY., SUITE 100 |
OKLAHOMA CITY,
OK
73104
|
|
Correspondent Contact |
CRAIG D SHIMASAKI |
Regulation Number | 866.3328
|
Classification Product Code |
|
Date Received | 07/13/1998 |
Decision Date | 08/25/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|