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FDA 510(k)

ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED

K-Number: K850150 · 1985-02-21

ApplicantGainor Medical
Decision Date1985-02-21
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical. It received FDA 510(k) clearance on 1985-02-21 under 510(k) number K850150. 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 ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED?

ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED is a medical device that received FDA 510(k) clearance on 1985-02-21. The listed applicant is Gainor Medical. The 510(k) number is K850150.

When did ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED receive FDA 510(k) clearance?

ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED received FDA 510(k) clearance on 1985-02-21, under 510(k) number K850150.

Who is the listed applicant for ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED?

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

What is the FDA product code for ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED?

The FDA product code for ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED is FMK.

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Other records listing Gainor Medical 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.

K850100BLOOD LANCETK844305GAINOR MEDICAL FLOWMAX NEEDLESK844306GAINOR MEDICAL SYRINGEK840950ZINC OXIDE TAPEK840945SKIN CLOSUREK840951FIRST AID BANDAGE

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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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