FDA 510(k)

PPH Saliva Collection Kit

K-Number: K240797 · 2024-10-11

Decision Date2024-10-11

Product CodeQBD

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: QBD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242820Puritan PurSafe Plus Collection and Transport SystemPuritan Medical Products, LLC K222771Sample Preservative FluidHangzhou Bioer Technology Co., Ltd.K233324Molecular Transport Media - MTMAlb Luz K221547InActiv BlueFertipro NV K212878Sample preservation solutionZhejiang Gene Science Co., Ltd.K231013DNA/RNA Shield SafeCollect Saliva Collection kitZymo Research

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.