MallyaD injection pen adapter (MallyaD)— 510(k) K250555

Name: FDA 510(k) clearance K250555
Creator: U.S. Food and Drug Administration
Published: 2025-03-27

Substantially Equivalent

Biocorp Production

FDA 510(k) clearance K250555 for MallyaD injection pen adapter (MallyaD), Substantially Equivalent on 2025-03-27. Applicant: Biocorp Production. Device class: 2.

Clearance details

Applicant: Biocorp Production
Product code: Code QOG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2025-02-25
Decision date: 2025-03-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Issoire, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOG

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K251500 — MallyaG Injection Pen Adapter (MallyaG)2025-06-09
K241803 — INSULCLOCK® v2.0 PRO2024-08-22
K231820 — SoloSmart Injection Pen Adapter (SoloSmart®)2024-01-12
K222689 — Mallya Injection Pen Adapter (Mallya® for Solostar®)2022-12-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.