The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Csf Total Protein Test Set #0340.
| Device ID | K780110 |
| 510k Number | K780110 |
| Device Name: | CSF TOTAL PROTEIN TEST SET #0340 |
| Classification | Turbidimetric, Total Protein |
| Applicant | STANBIO LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JGQ |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-19 |
| Decision Date | 1978-03-03 |