Product Code: IDY FDA class 1 21 CFR 864.3010

Bath, Flotation, Tissue

Pathology

A tissue flotation bath is a laboratory water bath used in histopathology to float and flatten thin paraffin-embedded tissue sections cut by the microtome onto a water surface before pickup onto glass slides, reducing wrinkles and folds in the section. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is IDY, regulated under 21 CFR 864.3010, in the Pathology medical specialty. This device is exempt from GMP requirements.

510(k)s
0
FEI Numbers
21
Registration Numbers
21
Unique Applicants
0
Years Active

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Basic Information

Product Code
IDY
Device Class
FDA class 1
Regulation Number
864.3010
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 21 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.