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 |