Product Code: HYH FDA class 1 21 CFR 864.1850

Gold Chloride

Hematology

Gold chloride is a histological staining reagent used in tissue section preparation to impregnate and visualize nerve fibers, synapses, and certain tissue structures by a gold-toning reduction process in neurohistology and pathology laboratories. It is classified as an FDA Class 1 device under 21 CFR 864.1850, indicating minimal risk and general controls. Product code HYH falls under the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

510(k)s
0
FEI Numbers
12
Registration Numbers
12
Unique Applicants
0
Years Active

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Basic Information

Product Code
HYH
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 12 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.