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FDA 510(k)

Mallya Injection Pen Adapter (Mallya® for Solostar®)

K-Number: K222689 · 2022-12-05

ApplicantBiocorp Production
Decision Date2022-12-05
Product CodeQOG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Mallya Injection Pen Adapter (Mallya® for Solostar®) is the device name listed in this FDA 510(k) record. The listed applicant is Biocorp Production. It received FDA 510(k) clearance on 2022-12-05 under 510(k) number K222689. The device is classified under product code QOG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mallya Injection Pen Adapter (Mallya® for Solostar®)?

Mallya Injection Pen Adapter (Mallya® for Solostar®) is a medical device that received FDA 510(k) clearance on 2022-12-05. The listed applicant is Biocorp Production. The 510(k) number is K222689.

When did Mallya Injection Pen Adapter (Mallya® for Solostar®) receive FDA 510(k) clearance?

Mallya Injection Pen Adapter (Mallya® for Solostar®) received FDA 510(k) clearance on 2022-12-05, under 510(k) number K222689.

Who is the listed applicant for Mallya Injection Pen Adapter (Mallya® for Solostar®)?

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

What is the FDA product code for Mallya Injection Pen Adapter (Mallya® for Solostar®)?

The FDA product code for Mallya Injection Pen Adapter (Mallya® for Solostar®) is QOG.

Other records listing Biocorp Production 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.

K251500MallyaG Injection Pen Adapter (MallyaG)K250555MallyaD injection pen adapter (MallyaD)K231820SoloSmart Injection Pen Adapter (SoloSmart®)

Related Devices (Code: QOG)

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.

K243901SmartPilot YpsoMate NS-A2.25Ypsomed AGK251500MallyaG Injection Pen Adapter (MallyaG)Biocorp ProductionK250555MallyaD injection pen adapter (MallyaD)Biocorp ProductionK241803INSULCLOCK® v2.0 PROInsulcloud S.L.K231820SoloSmart Injection Pen Adapter (SoloSmart®)Biocorp ProductionK212217Tempo Smart ButtonEli Lilly and Company

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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