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 |