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FDA 510(k)

LANCET, BLOOD

K-Number: K883420 · 1988-08-26

ApplicantPrimrose Medical, Inc.
Decision Date1988-08-26
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LANCET, BLOOD is the device name listed in this FDA 510(k) record. The listed applicant is Primrose Medical, Inc.. It received FDA 510(k) clearance on 1988-08-26 under 510(k) number K883420. 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 LANCET, BLOOD?

LANCET, BLOOD is a medical device that received FDA 510(k) clearance on 1988-08-26. The listed applicant is Primrose Medical, Inc.. The 510(k) number is K883420.

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

LANCET, BLOOD received FDA 510(k) clearance on 1988-08-26, under 510(k) number K883420.

Who is the listed applicant for LANCET, BLOOD?

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

What is the FDA product code for LANCET, BLOOD?

The FDA product code for LANCET, BLOOD is FMK.

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Other records listing Primrose Medical, 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.

K884713COLONIC BALLOON DIALATORSK884715ACHELASIA BALLOON DIALATORK884714BILIARY DIALATORK884711URETHRAL AND URETERAL BALLOON DILATATORSK884712ESOPHAGEAL AND PYLORIC BALLOON DIALATORSK884709ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)

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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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