FDA 510(k)

Rapid Tox Cup II

Número K: K170222 · 2017-08-15

Data da decisão2017-08-15

Código do produtoLAF

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

Rapid Tox Cup II is the device name listed in this FDA 510(k) record. The listed applicant is American Bio Medica Corp.. It received FDA 510(k) clearance on 2017-08-15 under 510(k) number K170222. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Rapid Tox Cup II?

Rapid Tox Cup II is a medical device that received FDA 510(k) clearance on 2017-08-15. The listed applicant is American Bio Medica Corp.. The 510(k) number is K170222.

When did Rapid Tox Cup II receive FDA 510(k) clearance?

Rapid Tox Cup II received FDA 510(k) clearance on 2017-08-15, under 510(k) number K170222.

Who is the listed applicant for Rapid Tox Cup II?

The FDA 510(k) record lists American Bio Medica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rapid Tox Cup II?

The FDA product code for Rapid Tox Cup II is LAF.

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