FDA 510(k)

PPH Saliva Collection Kit

Numéro K : K240797 · 2024-10-11

Date de décision2024-10-11

Code produitQBD

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

PPH Saliva Collection Kit is the device name listed in this FDA 510(k) record. The listed applicant is Permantis Public Health. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K240797. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the PPH Saliva Collection Kit?

PPH Saliva Collection Kit is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Permantis Public Health. The 510(k) number is K240797.

When did PPH Saliva Collection Kit receive FDA 510(k) clearance?

PPH Saliva Collection Kit received FDA 510(k) clearance on 2024-10-11, under 510(k) number K240797.

Who is the listed applicant for PPH Saliva Collection Kit?

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

What is the FDA product code for PPH Saliva Collection Kit?

The FDA product code for PPH Saliva Collection Kit is QBD.

Essais cliniques associés

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Dispositifs connexes (Code : QBD)

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Source officielle

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