Mission Trinity R (level 1) (level 2) (level 3), (level 1 +2 more)

FDA 510(k)EUDAMED

Class I (US FDA 510(k))

510(k) K093384

Identifiers

510(k) Number: K093384 FDA 510(k)
FDA Product Code: JJY FDA 510(k)
Models / Variants: level 1 FDA 510(k)EUDAMED
2 FDA 510(k)EUDAMED
3 FDA 510(k)EUDAMED

Classification

Device Class: Class I FDA 510(k)
Legislation / Framework: 21 CFR Part 862.1660 FDA 510(k)
Regulation Number: 862.1660 FDA 510(k)
Advisory Committee: Clinical Chemistry FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Mission Trinity R (level 1) (level 2) (level 3), (level 1 +2 more) by DIAMOND DIAGNOSTICS Inc — Class I — IVDR, FDA_510K — listed in FDA 510(k), EUDAMED — 3…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	Class I	Active
FDA 510(k)	United States	FDA_510K	K093384	Class I	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: DIAMOND DIAGNOSTICS Inc
FDA Applicant: Diamond Diagnostics, Inc.

Sources (2)

FDA 510(k) K093384 24 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced May 18, 2026