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FDA 510(k)

GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD

K-Number: K855203 · 1986-02-11

ApplicantMiles Laboratories, Inc.
Decision Date1986-02-11
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1986-02-11 under 510(k) number K855203. 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 GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD?

GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD is a medical device that received FDA 510(k) clearance on 1986-02-11. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K855203.

When did GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD receive FDA 510(k) clearance?

GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD received FDA 510(k) clearance on 1986-02-11, under 510(k) number K855203.

Who is the listed applicant for GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD?

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

What is the FDA product code for GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD?

The FDA product code for GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD is FMK.

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Other records listing Miles Laboratories, Inc. as applicant

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K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERK874909MICRO-BUMINTEST REAGENT TABLETSK875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEK871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK872120SERALYZER III BLOOD CHEMISTRY ANALYZERK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

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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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