510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050755Substantially Equivalent

Modification to Bvblue

Gryphus Diagnostics, L.L.C., Rockville MD / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K050755 is the FDA 510(k) clearance record for MODIFICATION TO BVBLUE, a class I device, cleared for Gryphus Diagnostics, LLC on under FDA product code MXB (Test, Vaginal, Bacterial Sialidase). FDA records list 2 510(k) clearances for Gryphus Diagnostics, LLC, from to . As of , FDA records show one recall naming K050755.

Clearance record

Decision date
Received
(14 days to decision)
Product code
MXB Test, Vaginal, Bacterial Sialidase
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Gryphus Diagnostics, LLC 16809 Briardale Rd., Rockville MD
510(k) summary
Statement
Third party review
No

Clearances, product code MXB

Trailing 12 months

FDA records hold no clearances under product code MXB in the trailing twelve months.

FDA records show no clearances under product code MXB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MXB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260