The following data is part of a premarket notification filed by Remel, L.p. with the FDA for Rpr Liquid Controls.
| Device ID | K955143 |
| 510k Number | K955143 |
| Device Name: | RPR LIQUID CONTROLS |
| Classification | Antisera, Control For Nontreponemal Tests |
| Applicant | REMEL, L.P. P.O. BOX 16276 Augusta, GA 30919 -2276 |
| Contact | David A Wall |
| Correspondent | David A Wall REMEL, L.P. P.O. BOX 16276 Augusta, GA 30919 -2276 |
| Product Code | GMP |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-07-30 |
| Summary: | summary |