The following data is part of a premarket notification filed by Quantitative Medicine, Inc. with the FDA for Quantimetrix Quan Test-red Protein Assay System.
| Device ID | K904603 |
| 510k Number | K904603 |
| Device Name: | QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | QUANTITATIVE MEDICINE, INC. 4955 WEST 145TH ST. Hawthorne, CA 90250 |
| Contact | S Johnson |
| Correspondent | S Johnson QUANTITATIVE MEDICINE, INC. 4955 WEST 145TH ST. Hawthorne, CA 90250 |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-10 |
| Decision Date | 1991-01-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M0515210120 | K904603 | 000 |