binx io CT/NG Assay and binx io CT/NG System— 510(k) K200533

Name: FDA 510(k) clearance K200533
Creator: U.S. Food and Drug Administration
Published: 2020-04-27

Substantially Equivalent

Binx Health, Inc.

FDA 510(k) clearance K200533 for binx io CT/NG Assay and binx io CT/NG System, Substantially Equivalent on 2020-04-27. Applicant: Binx Health, Inc.. Device class: 2.

Clearance details

Applicant: Binx Health, Inc.
Product code: Code QEP
Device class: Class 2
Regulation: 21 CFR 866.3393
Advisory panel: Microbiology
Date received: 2020-03-02
Decision date: 2020-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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K243343 — BD CTGCTV22025-04-22

More clearances from Binx Health, Inc.

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K191352 — binx health io CT/NG Assay2019-08-08

Recalls naming K200533

K-number listed on FDA's recall record

Z-1626-2023 — binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101Class II·Ongoing·Binx Health, Inc.·20230329

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200533.

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