Preservation Solutions, Inc.

FDA Regulatory Profile

Preservation Solutions, Inc. appears in FDA public data with 1 recall, 6 510(k) clearances, 10 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1387-2018, Class II) was initiated on February 26, 2018. Its most recent 510(k) clearance was granted on September 18, 2015.

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
10
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1387-2018Class IICold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; andFebruary 26, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K151728CoStorSol plus GSeptember 18, 2015
K091245COSTORSOLJune 17, 2009
K083453COSTORSOLJanuary 21, 2009
K080432MAPERSOLAugust 8, 2008
K073693COSTORSOLJuly 3, 2008
K022826CLEAR-IT ANTI-FOG, MODEL PS003October 9, 2002