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FDA 510(k)

GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD

K-Number: K902430 · 1990-08-02

ApplicantHeraeus Kulzer, Inc.
Decision Date1990-08-02
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1990-08-02 under 510(k) number K902430. 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 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD?

GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD is a medical device that received FDA 510(k) clearance on 1990-08-02. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K902430.

When did GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD receive FDA 510(k) clearance?

GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD received FDA 510(k) clearance on 1990-08-02, under 510(k) number K902430.

Who is the listed applicant for GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD?

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

What is the FDA product code for GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD?

The FDA product code for GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD is FMK.

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Other records listing Heraeus Kulzer, 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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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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