Device Classification Name |
enzyme immunoassay, benzodiazepine
|
510(k) Number |
K013882 |
Device Name |
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I |
Applicant |
ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. |
BETHLEHEM,
PA
18018 -1799
|
|
Applicant Contact |
R. SAM NIEDBALA |
Correspondent |
ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. |
BETHLEHEM,
PA
18018 -1799
|
|
Correspondent Contact |
R. SAM NIEDBALA |
Regulation Number | 862.3170
|
Classification Product Code |
|
Date Received | 11/23/2001 |
Decision Date | 04/17/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|