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FDA 510(k)

HEMASTICK 1-1.5 & 2-DISPOS. BLOOD

K-Number: K833816 · 1983-12-22

ApplicantMedprobe Laboratories
Decision Date1983-12-22
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEMASTICK 1-1.5 & 2-DISPOS. BLOOD is the device name listed in this FDA 510(k) record. The listed applicant is Medprobe Laboratories. It received FDA 510(k) clearance on 1983-12-22 under 510(k) number K833816. 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 HEMASTICK 1-1.5 & 2-DISPOS. BLOOD?

HEMASTICK 1-1.5 & 2-DISPOS. BLOOD is a medical device that received FDA 510(k) clearance on 1983-12-22. The listed applicant is Medprobe Laboratories. The 510(k) number is K833816.

When did HEMASTICK 1-1.5 & 2-DISPOS. BLOOD receive FDA 510(k) clearance?

HEMASTICK 1-1.5 & 2-DISPOS. BLOOD received FDA 510(k) clearance on 1983-12-22, under 510(k) number K833816.

Who is the listed applicant for HEMASTICK 1-1.5 & 2-DISPOS. BLOOD?

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

What is the FDA product code for HEMASTICK 1-1.5 & 2-DISPOS. BLOOD?

The FDA product code for HEMASTICK 1-1.5 & 2-DISPOS. BLOOD 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 Medprobe Laboratories 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.

K830001SUPERJET BTD BLEEDING TIME DEVICE DISPK830010SUPERJET LANCETK820625HEMALET AUTOMATIC LANCET DEVICE

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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