The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Diagnostic Reagent Pet-rpla.
| Device ID | K855235 |
| 510k Number | K855235 |
| Device Name: | DIAGNOSTIC REAGENT PET-RPLA |
| Classification | Kit, Anaerobic Identification |
| Applicant | OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Ruth Kemp |
| Correspondent | Ruth Kemp OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | JSP |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-31 |
| Decision Date | 1986-11-04 |