The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Challenge (tm) Liq Thera Drug Controls.
| Device ID | K910333 |
| 510k Number | K910333 |
| Device Name: | CHALLENGE (TM) LIQ THERA DRUG CONTROLS |
| Classification | Drug Mixture Control Materials |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Contact | Donna L Anderson |
| Correspondent | Donna L Anderson 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 | 1991-01-25 |
| Decision Date | 1991-04-12 |