Device Classification Name |
Enzyme Immunoassay, Amphetamine
|
510(k) Number |
K052115 |
Device Name |
FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY |
Applicant |
FIRST CHECK DIAGNOSTICS LLC |
13 SPECTRUM POINTE DR. |
LAKE FOREST,
CA
92630
|
|
Applicant Contact |
KEVIN J GADAWSKI |
Correspondent |
FIRST CHECK DIAGNOSTICS LLC |
13 SPECTRUM POINTE DR. |
LAKE FOREST,
CA
92630
|
|
Correspondent Contact |
KEVIN J GADAWSKI |
Regulation Number | 862.3100
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/04/2005 |
Decision Date | 12/29/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|