ACTIVE® Free Testosterone RIA

Radioimmunoassay, Testosterones And Dihydrotestosterone

Immunotech S.r.o.

The following data is part of a premarket notification filed by Immunotech S.r.o. with the FDA for Active® Free Testosterone Ria.

Pre-market Notification Details

• Device ID: K191350
• 510k Number: K191350
• Device Name: ACTIVE® Free Testosterone RIA
• Classification: Radioimmunoassay, Testosterones And Dihydrotestosterone
• Applicant: Immunotech S.r.o. Radiova 1 Prague, CZ 10227
• Contact: Vit Oburka
• Correspondent: Vit Oburka; Immunotech S.r.o. Radiova 1 Prague, CZ 10227
• Product Code: CDZ
• CFR Regulation Number: 862.1680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-20
• Decision Date: 2019-12-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590211530	K191350	000