Device Classification Name |
antigens, cf (including cf control), influenza virus a, b, c
|
510(k) Number |
K971494 |
Device Name |
VIRAZYME INFLUENZA ID 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 | 866.3330
|
Classification Product Code |
|
Date Received | 04/24/1997 |
Decision Date | 09/10/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|