ClearanceBrief
Panels › Immunology › Product code DGW · Class 2

System, Test, Hypersensitivity Pneumonitis

Regulation 866.5500

0510(k)s in 12 months (0 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
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Top companies in DGW

Company510(k)sRecalls
Greer Laboratories, Inc.02
DateFirm and productCodeLinked 510(k)
Nov 30, 2022Greer Laboratories, Inc.
GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
Terminated
DGWNone listed
Nov 30, 2022Greer Laboratories, Inc.
GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
Terminated
DGWNone listed

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