The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Doa-xse, Liquid Drugs Of Abuse Control Levels 2,3, And 4 (sdoa- 202,303,404).
| Device ID | K971058 |
| 510k Number | K971058 |
| Device Name: | DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404) |
| Classification | Drug Mixture Control Materials |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Contact | Scot Kinghorn |
| Correspondent | Scot Kinghorn MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-24 |
| Decision Date | 1997-04-08 |