Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LetsGetChecked Impress

K-Number: K242680 · 2025-01-13

ApplicantPrivapath Diagnostics Ltd (Dba Letsgetchecked)
Decision Date2025-01-13
Product CodeFMK
Advisory CommitteeSU
DecisionUnknown

Device Summary

LetsGetChecked Impress is the device name listed in this FDA 510(k) record. The listed applicant is Privapath Diagnostics Ltd (Dba Letsgetchecked). It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K242680. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the LetsGetChecked Impress?

LetsGetChecked Impress is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Privapath Diagnostics Ltd (Dba Letsgetchecked). The 510(k) number is K242680.

When did LetsGetChecked Impress receive FDA 510(k) clearance?

LetsGetChecked Impress received FDA 510(k) clearance on 2025-01-13, under 510(k) number K242680.

Who is the listed applicant for LetsGetChecked Impress?

The FDA 510(k) record lists Privapath Diagnostics Ltd (Dba Letsgetchecked) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LetsGetChecked Impress?

The FDA product code for LetsGetChecked Impress is FMK.

Related Devices (Code: FMK)

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.

K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.K251694safety lancetTianjin Huahong Technology Co., Ltd.K244036Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc.

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.

↑