The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Rub-e.i.a. Test G.
| Device ID | K894544 |
| 510k Number | K894544 |
| Device Name: | BIOTROL RUB-E.I.A. TEST G |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester, PA 19380 |
| Contact | Allan C Murphy |
| Correspondent | Allan C Murphy BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester, PA 19380 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-08-30 |