Product Code: HYS FDA class 1 21 CFR 864.1850

Light Green

Hematology

Light green is a synthetic dye used as a histological counterstain to color cytoplasm, collagen, and other acidophilic tissue structures green in conjunction with other nuclear stains such as iron hematoxylin, frequently employed in Masson's trichrome and similar protocols. It is classified as an FDA Class 1 device under 21 CFR 864.1850, indicating minimal risk and general controls. Product code HYS falls under the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

510(k)s
1
FEI Numbers
11
Registration Numbers
11
Unique Applicants
1
Years Active

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Basic Information

Product Code
HYS
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

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
K842927 LIGHT GREEN SF 1%

FEI Numbers

This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.