Device Classification Name |
Antigens, All Types, Escherichia Coli
|
510(k) Number |
K980507 |
Device Name |
PROSPECT SHIGA TOXIN MICROPLATE ASSAY |
Applicant |
ALEXON - TREND, INC. |
14000 UNITY ST., N.W. |
RAMSEY,
MN
55303 -9115
|
|
Applicant Contact |
BARBARA A CHIPONIS, MT (ASCP) |
Correspondent |
ALEXON - TREND, INC. |
14000 UNITY ST., N.W. |
RAMSEY,
MN
55303 -9115
|
|
Correspondent Contact |
BARBARA A CHIPONIS, MT (ASCP) |
Regulation Number | 866.3255
|
Classification Product Code |
|
Date Received | 02/10/1998 |
Decision Date | 04/23/1998 |
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
|
|
|