MODIFICATION TO BVBLUE— 510(k) K050755

Name: FDA 510(k) clearance K050755
Creator: U.S. Food and Drug Administration
Published: 2005-04-06

Substantially Equivalent

Gryphus Diagnostics, LLC

FDA 510(k) clearance K050755 for MODIFICATION TO BVBLUE, Substantially Equivalent on 2005-04-06. Applicant: Gryphus Diagnostics, LLC. Device class: 1.

Clearance details

Applicant: Gryphus Diagnostics, LLC
Product code: Code MXB
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2005-03-23
Decision date: 2005-04-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MXB

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K993732 — BVBLUE2000-05-15

Recalls naming K050755

K-number listed on FDA's recall record

Z-1311-2024 — Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial VaginosisClass II·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·20240109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050755.

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