Binx Health, Inc.

FDA Regulatory Profile

Binx Health, Inc. appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1626-2023, Class II) was initiated on March 29, 2023. Its most recent 510(k) clearance was granted on April 27, 2020.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1626-2023Class IIbinx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis andMarch 29, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K200533binx io CT/NG Assay and binx io CT/NG SystemApril 27, 2020
K191352binx health io CT/NG AssayAugust 8, 2019