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FDA 510(k)

SUPERJET BTD BLEEDING TIME DEVICE DISP

K-Number: K830001 · 1983-09-26

ApplicantMedprobe Laboratories
Decision Date1983-09-26
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUPERJET BTD BLEEDING TIME DEVICE DISP is the device name listed in this FDA 510(k) record. The listed applicant is Medprobe Laboratories. It received FDA 510(k) clearance on 1983-09-26 under 510(k) number K830001. 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 BTD BLEEDING TIME DEVICE DISP?

SUPERJET BTD BLEEDING TIME DEVICE DISP is a medical device that received FDA 510(k) clearance on 1983-09-26. The listed applicant is Medprobe Laboratories. The 510(k) number is K830001.

When did SUPERJET BTD BLEEDING TIME DEVICE DISP receive FDA 510(k) clearance?

SUPERJET BTD BLEEDING TIME DEVICE DISP received FDA 510(k) clearance on 1983-09-26, under 510(k) number K830001.

Who is the listed applicant for SUPERJET BTD BLEEDING TIME DEVICE DISP?

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 SUPERJET BTD BLEEDING TIME DEVICE DISP?

The FDA product code for SUPERJET BTD BLEEDING TIME DEVICE DISP is FMK.

Related Clinical Trials

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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.

K833816HEMASTICK 1-1.5 & 2-DISPOS. BLOODK830010SUPERJET 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

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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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