The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Diagnostic Reagent Tst-rpla.
| Device ID | K855236 |
| 510k Number | K855236 |
| Device Name: | DIAGNOSTIC REAGENT TST-RPLA |
| Classification | Antisera, Fluorescent, All Types, Staphylococcus Spp. |
| 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 | GTN |
| CFR Regulation Number | 866.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-31 |
| Decision Date | 1986-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05032384029594 | K855236 | 000 |