The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Mas Bilirubin Liquid Assayed Bilirubin Control.
| Device ID | K031890 |
| 510k Number | K031890 |
| Device Name: | MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL |
| Classification | Single (specified) Analyte 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-18 |
| Decision Date | 2003-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883004634 | K031890 | 000 |
| 00884883004627 | K031890 | 000 |
| 00884883004610 | K031890 | 000 |
| 00884883003866 | K031890 | 000 |
| 00884883003859 | K031890 | 000 |
| 00884883003842 | K031890 | 000 |
| 00884883003835 | K031890 | 000 |