Device Classification Name |
antisera, all groups, streptococcus spp.
|
510(k) Number |
K962060 |
Device Name |
STREP A OIA MAX |
Applicant |
BIOSTAR, INC. |
6655 LOOKOUT RD. |
BOULDER,
CO
80301
|
|
Applicant Contact |
LYNDAL K HESTERBERG |
Correspondent |
BIOSTAR, INC. |
6655 LOOKOUT RD. |
BOULDER,
CO
80301
|
|
Correspondent Contact |
LYNDAL K HESTERBERG |
Regulation Number | 866.3740
|
Classification Product Code |
|
Date Received | 05/28/1996 |
Decision Date | 07/23/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|