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FDA 510(k)

MEDI-LANCE

K-Number: K810681 · 1981-03-26

ApplicantMedicore, Inc.
Decision Date1981-03-26
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDI-LANCE is the device name listed in this FDA 510(k) record. The listed applicant is Medicore, Inc.. It received FDA 510(k) clearance on 1981-03-26 under 510(k) number K810681. 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 MEDI-LANCE?

MEDI-LANCE is a medical device that received FDA 510(k) clearance on 1981-03-26. The listed applicant is Medicore, Inc.. The 510(k) number is K810681.

When did MEDI-LANCE receive FDA 510(k) clearance?

MEDI-LANCE received FDA 510(k) clearance on 1981-03-26, under 510(k) number K810681.

Who is the listed applicant for MEDI-LANCE?

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

What is the FDA product code for MEDI-LANCE?

The FDA product code for MEDI-LANCE is FMK.

Related Clinical Trials

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.

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Other records listing Medicore, Inc. as applicant

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.

K983430LITE-TOUCH SYRINGEK880869MEDI-LET

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

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

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