The following data is part of a premarket notification filed by Genmark Diagnostics, Incorporated with the FDA for Eplex Blood Culture Identification Panel - Gram Positive (bcid-gp) Panel.
Device ID | K181663 |
510k Number | K181663 |
Device Name: | EPlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel |
Classification | Gram-positive Bacteria And Their Resistance Markers |
Applicant | GenMark Diagnostics, Incorporated 5964 La Place Court Carlsbad, CA 92008 |
Contact | Alan Maderazo |
Correspondent | Alan Maderazo GenMark Diagnostics, Incorporated 5964 La Place Court Carlsbad, CA 92008 |
Product Code | PAM |
Subsequent Product Code | PEN |
Subsequent Product Code | PEO |
CFR Regulation Number | 866.3365 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-25 |
Decision Date | 2018-12-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857167005337 | K181663 | 000 |
00857167005320 | K181663 | 000 |