Device Classification Name |
Gas Chromatography, Methamphetamine
|
510(k) Number |
K003352 |
Device Name |
ESCREEN SYSTEM |
Applicant |
ESCREEN, INC. |
555 THIRTEENTH ST. N.W. |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
ESCREEN, INC. |
555 THIRTEENTH ST. N.W. |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 862.3610
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/26/2000 |
Decision Date | 03/20/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|