The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Syphilis Rpr Test, No. 1170.
| Device ID | K880144 |
| 510k Number | K880144 |
| Device Name: | STANBIO SYPHILIS RPR TEST, NO. 1170 |
| Classification | Antigens, Nontreponemal, All |
| Applicant | STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Contact | William Campbell,phd |
| Correspondent | William Campbell,phd STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Product Code | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-13 |
| Decision Date | 1988-05-23 |