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FDA 510(k)

DIALET LANCING DEVICE

K-Number: K861265 · 1986-04-30

ApplicantHome Diagnostics, Inc.
Decision Date1986-04-30
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIALET LANCING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Home Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-04-30 under 510(k) number K861265. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALET LANCING DEVICE?

DIALET LANCING DEVICE is a medical device that received FDA 510(k) clearance on 1986-04-30. The listed applicant is Home Diagnostics, Inc.. The 510(k) number is K861265.

When did DIALET LANCING DEVICE receive FDA 510(k) clearance?

DIALET LANCING DEVICE received FDA 510(k) clearance on 1986-04-30, under 510(k) number K861265.

Who is the listed applicant for DIALET LANCING DEVICE?

The FDA 510(k) record lists Home Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIALET LANCING DEVICE?

The FDA product code for DIALET LANCING DEVICE is FMK.

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Other records listing Home Diagnostics, Inc. as applicant

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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.

K262526Safety lancet (XL)Tianjin Huahong Technology Co., Ltd.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.

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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