The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Mas Ua Control Liquid Assayed Urinalysis Control, Dade Assayed Urinalysis Control.
| Device ID | K023928 |
| 510k Number | K023928 |
| Device Name: | MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012 |
| Contact | Penny M Layman |
| Correspondent | Penny M Layman MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-25 |
| Decision Date | 2002-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883003958 | K023928 | 000 |