The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor.
Device ID | K191562 |
510k Number | K191562 |
Device Name: | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor |
Classification | Ferritin, Antigen, Antiserum, Control |
Applicant | HORIBA ABX SAS Parc Euromedecine, Rue Du Caducee BP7290 Montpellier Cedex 4, FR 341184 |
Contact | Caroline Ferrer |
Correspondent | Caroline Ferrer HORIBA ABX SAS Parc Euromedecine, Rue Du Caducee BP7290 Montpellier Cedex 4, FR 341184 |
Product Code | DBF |
Subsequent Product Code | DDG |
Subsequent Product Code | DHR |
CFR Regulation Number | 866.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-06-13 |
Decision Date | 2020-03-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03610230007419 | K191562 | 000 |
03610230007402 | K191562 | 000 |
03610230007327 | K191562 | 000 |