Device Classification Name |
nucleic acid amplification assay system, group b streptococcus, direct specimen test
|
510(k) Number |
K022504 |
Device Name |
IDI-STREP B ASSAY |
Applicant |
INFECTIO DIAGNOSTIC, INC. |
P.O. BOX 103 |
BALDWIN,
MD
21013
|
|
Applicant Contact |
Judi Smith |
Correspondent |
INFECTIO DIAGNOSTIC, INC. |
P.O. BOX 103 |
BALDWIN,
MD
21013
|
|
Correspondent Contact |
Judi Smith |
Regulation Number | 866.3740
|
Classification Product Code |
|
Date Received | 07/29/2002 |
Decision Date | 11/18/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|