The following data is part of a premarket notification filed by Remel, L.p. with the FDA for Rpr Card Test Kit.
| Device ID | K955136 |
| 510k Number | K955136 |
| Device Name: | RPR CARD TEST KIT |
| Classification | Antigens, Nontreponemal, All |
| 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 | GMQ |
| 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 | 1996-07-29 |
| Summary: | summary |