| Device Classification Name |
Drug Mixture Control Materials
|
| 510(k) Number |
K934498 |
| Device Name |
DOA LIQUID DRUGS OF ABUSE CONTROLS |
| Applicant |
| Medical Analysis Systems, Inc. |
| 542 Flynn Rd. |
|
Camarillo,
CA
93012
|
|
| Applicant Contact |
DONNA L ANDERSON |
| Correspondent |
| Medical Analysis Systems, Inc. |
| 542 Flynn Rd. |
|
Camarillo,
CA
93012
|
|
| Correspondent Contact |
DONNA L ANDERSON |
| Regulation Number | 862.3280 |
| Classification Product Code |
|
| Date Received | 09/15/1993 |
| Decision Date | 07/06/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Toxicology
|
| 510k Review Panel |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|