The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Rapet Rf.
| Device ID | K974370 |
| 510k Number | K974370 |
| Device Name: | RAPET RF |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Contact | Kirk Johnson |
| Correspondent | Kirk Johnson STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-20 |
| Decision Date | 1998-02-17 |
| Summary: | summary |