IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibratio…

FDA 510(k)EUDAMED

Class I (US FDA 510(k))

510(k) K161082

Identifiers

510(k) Number: K161082 FDA 510(k)
FDA Product Code: JJX 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)

IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibratio… by Immunodiagnostic Systems , Ltd. — Class I — IVDD, FDA_510K — listed in FDA…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDD	—	Class I	Active
FDA 510(k)	United States	FDA_510K	K161082	Class I	Active

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Manufacturer

Manufacturer: Immunodiagnostic Systems , Ltd.

Sources (2)

FDA 510(k) K161082 24 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced May 19, 2026