Device Classification Name |
Enzyme Immunoassay, Phenobarbital
|
510(k) Number |
K993031 |
Device Name |
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 |
Applicant |
SYVA CO. |
3403 YERBA BUENA RD. |
SAN JOSE,
CA
95161 -9013
|
|
Applicant Contact |
PAUL L ROGERS |
Correspondent |
SYVA CO. |
3403 YERBA BUENA RD. |
SAN JOSE,
CA
95161 -9013
|
|
Correspondent Contact |
PAUL L ROGERS |
Regulation Number | 862.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/09/1999 |
Decision Date | 01/27/2000 |
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
|
|
|