The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Opiates 2000 Liquid Opiates Drugs Of Abuse Control Levels G2 And G3.
| Device ID | K983127 |
| 510k Number | K983127 |
| Device Name: | OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3 |
| Classification | Drug Mixture Control Materials |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Contact | Mary Thorsness |
| Correspondent | Mary Thorsness MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-08 |
| Decision Date | 1998-09-14 |