BIOSTAR OIA SHIGATOX— 510(k) K061889

Name: FDA 510(k) clearance K061889
Creator: U.S. Food and Drug Administration
Published: 2006-12-12

Substantially Equivalent

Inverness Medical-Biostar, Inc.

FDA 510(k) clearance K061889 for BIOSTAR OIA SHIGATOX, Substantially Equivalent on 2006-12-12. Applicant: Inverness Medical-Biostar, Inc.. Device class: 1.

Clearance details

Applicant: Inverness Medical-Biostar, Inc.
Product code: Code GMZ
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 2006-07-03
Decision date: 2006-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K061889

K-number listed on FDA's recall record

Z-0965-2017 — EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes.Class II·Terminated·Advanced Sterilization Products·20160927

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061889.

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