The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Reference Assayed Chemistry Control Serum.
Device ID | K874810 |
510k Number | K874810 |
Device Name: | REFERENCE ASSAYED CHEMISTRY CONTROL SERUM |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern, PA 19355 |
Contact | Allan C Murphy |
Correspondent | Allan C Murphy BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern, PA 19355 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-23 |
Decision Date | 1988-01-05 |