The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Csf/urine Total Protein Test Set.
| Device ID | K902204 |
| 510k Number | K902204 |
| Device Name: | STANBIO CSF/URINE TOTAL PROTEIN TEST SET |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Contact | Judith A Harbour |
| Correspondent | Judith A Harbour STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-16 |
| Decision Date | 1990-08-22 |