Greer Laboratories, Inc.

FDA Regulatory Profile

Greer Laboratories, Inc. appears in FDA public data with 2 recalls, 2 510(k) clearances, 11 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0347-2023, Class II) was initiated on October 25, 2022. Its most recent 510(k) clearance was granted on December 13, 2000.

Summary

Total Recalls
2
510(k) Clearances
2
Inspections
11
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0347-2023Class IIGREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS tOctober 25, 2022
Z-0348-2023Class IIGREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVOctober 25, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K003195GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-ICDecember 13, 2000
K890360GREER DERMAPIK SYSTEMJune 23, 1989