The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Calibrant Level 3.
Device ID | K875318 |
510k Number | K875318 |
Device Name: | BIOTROL CALIBRANT LEVEL 3 |
Classification | Calibrator, Multi-analyte Mixture |
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 | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-29 |
Decision Date | 1988-02-02 |