The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Paramax Cerebrospinal Fluid/urine Protein Blank.
| Device ID | K903914 |
| 510k Number | K903914 |
| Device Name: | PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK |
| Classification | Turbidimetric, Total Protein |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Dana Jones |
| Correspondent | Dana Jones BAXTER HEALTHCARE CORP. P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | JGQ |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-24 |
| Decision Date | 1990-10-03 |