The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Csf/urine Total Protein.
| Device ID | K961864 |
| 510k Number | K961864 |
| Device Name: | CSF/URINE TOTAL PROTEIN |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Contact | K.c. Chen, Ph.d. |
| Correspondent | K.c. Chen, Ph.d. TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-14 |
| Decision Date | 1996-10-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486002171 | K961864 | 000 |