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FDA 510(k)

Kolplast Cervical Sample Collection Kit

K-Number: K153128 · 2017-01-13

ApplicantKolplast CI SA
Decision Date2017-01-13
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Kolplast Cervical Sample Collection Kit is a medical device manufactured by Kolplast CI SA. It received FDA 510(k) clearance on 2017-01-13 under approval number K153128. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kolplast Cervical Sample Collection Kit?

Kolplast Cervical Sample Collection Kit is a medical device that received FDA 510(k) clearance on 2017-01-13. It is manufactured by Kolplast CI SA. The 510(k) number is K153128.

When was Kolplast Cervical Sample Collection Kit approved by the FDA?

Kolplast Cervical Sample Collection Kit received FDA 510(k) clearance on 2017-01-13, under approval number K153128.

What company makes Kolplast Cervical Sample Collection Kit?

Kolplast Cervical Sample Collection Kit is manufactured by Kolplast CI SA.

What is the FDA product code for Kolplast Cervical Sample Collection Kit?

The FDA product code for Kolplast Cervical Sample Collection Kit is HHT.

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Official Source

View on FDA Database →

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

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