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FDA 510(k)

SUPERJET DISPOSABLE BLOOD LANCET

K-Number: K833812 · 1983-12-12

ApplicantMedrobe Laboratories
Decision Date1983-12-12
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUPERJET DISPOSABLE BLOOD LANCET is the device name listed in this FDA 510(k) record. The listed applicant is Medrobe Laboratories. It received FDA 510(k) clearance on 1983-12-12 under 510(k) number K833812. 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 SUPERJET DISPOSABLE BLOOD LANCET?

SUPERJET DISPOSABLE BLOOD LANCET is a medical device that received FDA 510(k) clearance on 1983-12-12. The listed applicant is Medrobe Laboratories. The 510(k) number is K833812.

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

SUPERJET DISPOSABLE BLOOD LANCET received FDA 510(k) clearance on 1983-12-12, under 510(k) number K833812.

Who is the listed applicant for SUPERJET DISPOSABLE BLOOD LANCET?

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

What is the FDA product code for SUPERJET DISPOSABLE BLOOD LANCET?

The FDA product code for SUPERJET DISPOSABLE BLOOD LANCET is FMK.

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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

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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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