Metrex Research, LLC.

FDA Regulatory Profile

Metrex Research, LLC. appears in FDA public data with 3 recalls, 6 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1402-2017, Class II) was initiated on January 20, 2017. Its most recent 510(k) clearance was granted on April 30, 1998.

Summary

Total Recalls
3
510(k) Clearances
6
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1402-2017Class IICaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a January 20, 2017
Z-2267-2012Class IICaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, parFebruary 6, 2012
Z-0444-2013Class IIPentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of thSeptember 20, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K981023KLEENASEPTICApril 30, 1998
K950516COLDCIDE-10March 22, 1995
K950553COLDCIDE-2March 22, 1995
K931052METRICIDE 28December 6, 1994
K931592METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDEDecember 6, 1994
K930284METRICIDEDecember 6, 1994