Device Classification Name |
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
|
510(k) Number |
K001552 |
Device Name |
TREPCHEK TREPONEMAL ANTIBODY EIA |
Applicant |
PHOENIX BIOTECH CORP. |
53 CEDAR LAKE RD. |
BLAIRSTOWN,
NJ
07825
|
|
Applicant Contact |
Gary Lehnus |
Correspondent |
PHOENIX BIOTECH CORP. |
53 CEDAR LAKE RD. |
BLAIRSTOWN,
NJ
07825
|
|
Correspondent Contact |
Gary Lehnus |
Regulation Number | 866.3830
|
Classification Product Code |
|
Date Received | 05/18/2000 |
Decision Date | 10/19/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|