Product Code: HYE FDA class 1 21 CFR 864.1850

Solution, Fontanna Silver

Hematology

Fontana silver solution is a histological staining reagent used in tissue sections to demonstrate melanin, argentaffin granules (such as those found in carcinoid tumors), and certain neurological structures through a silver reduction reaction. It is classified as an FDA Class 1 device under 21 CFR 864.1850, indicating minimal risk and general controls. Product code HYE falls under the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

510(k)s
0
FEI Numbers
5
Registration Numbers
5
Unique Applicants
0
Years Active

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Basic Information

Product Code
HYE
Device Class
FDA class 1
Regulation Number
864.1850
Medical Specialty
Hematology
Review Panel
PA
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

FEI Numbers

This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.