The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Mas, Dade And Liquid Assayed Diabetes Control.
| Device ID | K042717 |
| 510k Number | K042717 |
| Device Name: | MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012 |
| Contact | Mary Thorsness |
| Correspondent | Mary Thorsness MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-30 |
| Decision Date | 2004-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883004429 | K042717 | 000 |
| 00884883003521 | K042717 | 000 |
| 00884883003514 | K042717 | 000 |