Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Results for “NOVEOS Oyster, Ostrea edulis F290”
Name, manufacturer or identifier
Search
Manufacturer
(optional)
Filters
Filters
Registry
EUDAMED
FDA 510(k) incl. De Novo
1
FDA PMA
GUDID
2
Country / market
United States
3
Risk class
Class I
Class IIa
Class IIb
Class III
Class II (US)
3
More classes (11)
Class A
Class B
Class C
Class D
IVD General
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
Active implantable (AIMDD)
Unclassified (FDA)
Not classified (FDA)
Verified
Verified only
Category (EMDN)
Browse by category
Apply filters
3 devices found
·
sorted by relevance
Key
Clear all
Device
Device · Manufacturer · Authorizations
Verified
Verified
Status
Status
Regime
Regime
Registry
Registry
Class
Class
NOVEOS Oyster, Ostrea edulis F290
Hycor Biomedical LLC
·
,
United States
Group of variants
GUDID
on market
None
Registry:
GUDID
Class
Class:
II
NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)
Hycor Biomedical LLC
·
,
United States
FDA 510(k)
K260059
Active
Cleared 15 May 2026
Active
Regimes:
510(k)
Registry:
510(k)
Class
Class:
II
Previous
Next
Showing 1-3 of 3