The following data is part of a premarket notification filed by Diasorin Molecular Llc with the FDA for Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack.
Device ID | K173498 |
510k Number | K173498 |
Device Name: | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack |
Classification | Bordetella Pertussis Dna Assay System |
Applicant | DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 |
Contact | Sharon Young |
Correspondent | Sharon Young DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 |
Product Code | OZZ |
CFR Regulation Number | 866.3980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-13 |
Decision Date | 2018-08-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20816101025637 | K173498 | 000 |
20816101025620 | K173498 | 000 |