The following data is part of a premarket notification filed by Maine Molecular Quality Controls, Inc. with the FDA for Filmarray Pneumonia/pneumoniaplus Control.
Device ID | K190222 |
510k Number | K190222 |
Device Name: | FilmArray Pneumonia/Pneumoniaplus Control |
Classification | Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays |
Applicant | Maine Molecular Quality Controls, Inc. 23 Mill Brook Road Saco, ME 04072 |
Contact | Joan Gordon |
Correspondent | Joan Gordon Maine Molecular Quality Controls, Inc. 23 Mill Brook Road Saco, ME 04072 |
Product Code | PMN |
CFR Regulation Number | 866.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-05 |
Decision Date | 2019-05-03 |