Simple Diagnostics, Inc.

FDA Regulatory Profile

Simple Diagnostics, Inc. appears in FDA public data with 1 recall, 3 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0134-2018, Class II) was initiated on September 5, 2017. Its most recent 510(k) clearance was granted on December 6, 2012.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0134-2018Class IIAlcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by SimpSeptember 5, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K122787COMFORT EZDecember 6, 2012
K120921CLEVER CHOICEAugust 21, 2012
K121632COMFORT EZAugust 10, 2012