Mission Clinicheck Assayed Chemistry Control, Level 1&2, Mission Clinical Calib…

FDA 510(k)EUDAMED

Class I (US FDA 510(k))

510(k) K093492

Identifiers

510(k) Number: K093492 FDA 510(k)
FDA Product Code: JJY FDA 510(k)

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 Clinicheck Assayed Chemistry Control, Level 1&2, Mission Clinical Calib… by DIAMOND DIAGNOSTICS Inc — Class I — IVDR, FDA_510K — listed in FDA 510(k)…

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	K093492	Class I	Active

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Manufacturer

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

Sources (2)

FDA 510(k) K093492 24 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced May 18, 2026