The following data is part of a premarket notification filed by Biofire Diagnostics, Inc. with the FDA for Filmarray Blood Culture Identification (bcid) Panel.
Device ID | K130914 |
510k Number | K130914 |
Device Name: | FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL |
Classification | Gram-negative Bacteria And Associated Resistance Markers |
Applicant | BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City, UT 84108 |
Contact | Beth Lingenfelter |
Correspondent | Beth Lingenfelter BIOFIRE DIAGNOSTICS, INC. 390 Wakara Way Salt Lake City, UT 84108 |
Product Code | PEN |
Subsequent Product Code | OOI |
Subsequent Product Code | PAM |
Subsequent Product Code | PEO |
CFR Regulation Number | 866.3365 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-02 |
Decision Date | 2013-06-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00815381020093 | K130914 | 000 |
00815381020086 | K130914 | 000 |