Product Code: IFL FDA class 1 21 CFR 864.4010

Polyethylene Glycol Preservative

Pathology

Polyethylene Glycol Preservative is a wax-based fixative and preservative used in cytopathology to coat and protect cellular smears on glass slides, acting as an alternative to spray fixatives for preserving cytological specimens prior to laboratory staining. It is regulated as an FDA Class 1 device, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is IFL, regulated under 21 CFR 864.4010, in the Pathology medical specialty. This device is exempt from GMP requirements.

510(k)s
0
FEI Numbers
3
Registration Numbers
3
Unique Applicants
0
Years Active

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Basic Information

Product Code
IFL
Device Class
FDA class 1
Regulation Number
864.4010
Medical Specialty
Pathology
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 3 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.