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FDA 510(k)

SUEL BLOOD LANCET

K-Number: K861151 · 1986-04-15

ApplicantExel Intl.
Decision Date1986-04-15
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUEL BLOOD LANCET is the device name listed in this FDA 510(k) record. The listed applicant is Exel Intl.. It received FDA 510(k) clearance on 1986-04-15 under 510(k) number K861151. 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 SUEL BLOOD LANCET?

SUEL BLOOD LANCET is a medical device that received FDA 510(k) clearance on 1986-04-15. The listed applicant is Exel Intl.. The 510(k) number is K861151.

When did SUEL BLOOD LANCET receive FDA 510(k) clearance?

SUEL BLOOD LANCET received FDA 510(k) clearance on 1986-04-15, under 510(k) number K861151.

Who is the listed applicant for SUEL BLOOD LANCET?

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

What is the FDA product code for SUEL BLOOD LANCET?

The FDA product code for SUEL BLOOD LANCET is FMK.

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Other records listing Exel Intl. 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.

K992290EXEL INJECTION PLUG WITH CAPK963658EXEL AVF SINGLE NEEDLEK963659EXEL I.V. ADMINISTRATION SETK926119EXEL HUBER INFUSION SET ROTATING WINGK904685EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)K903945EXEL A-V FISTULA SET

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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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