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FDA 510(k)

PLANCET

K-Number: K113513 · 2012-07-13

ApplicantMicropoint Technologies Pte, Ltd.
Decision Date2012-07-13
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLANCET is the device name listed in this FDA 510(k) record. The listed applicant is Micropoint Technologies Pte, Ltd.. It received FDA 510(k) clearance on 2012-07-13 under 510(k) number K113513. 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 PLANCET?

PLANCET is a medical device that received FDA 510(k) clearance on 2012-07-13. The listed applicant is Micropoint Technologies Pte, Ltd.. The 510(k) number is K113513.

When did PLANCET receive FDA 510(k) clearance?

PLANCET received FDA 510(k) clearance on 2012-07-13, under 510(k) number K113513.

Who is the listed applicant for PLANCET?

The FDA 510(k) record lists Micropoint Technologies Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLANCET?

The FDA product code for PLANCET is FMK.

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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

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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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