FDA 510(k)

Immunalysis Tapentadol Urine HEIA

Número K: K203527 · 2022-05-09

Data da decisão2022-05-09

Código do produtoDJG

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

Immunalysis Tapentadol Urine HEIA is the device name listed in this FDA 510(k) record. The listed applicant is Lmmunalysis Corporation. It received FDA 510(k) clearance on 2022-05-09 under 510(k) number K203527. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Immunalysis Tapentadol Urine HEIA?

Immunalysis Tapentadol Urine HEIA is a medical device that received FDA 510(k) clearance on 2022-05-09. The listed applicant is Lmmunalysis Corporation. The 510(k) number is K203527.

When did Immunalysis Tapentadol Urine HEIA receive FDA 510(k) clearance?

Immunalysis Tapentadol Urine HEIA received FDA 510(k) clearance on 2022-05-09, under 510(k) number K203527.

Who is the listed applicant for Immunalysis Tapentadol Urine HEIA?

The FDA 510(k) record lists Lmmunalysis Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Immunalysis Tapentadol Urine HEIA?

The FDA product code for Immunalysis Tapentadol Urine HEIA is DJG.

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