Product Code: IEH FDA class 1 21 CFR 864.3010

Lamps, Slide Warming

Pathology

Slide warming lamps are heating accessories used in histopathology to dry freshly mounted tissue sections on glass slides, providing gentle warmth to promote adhesion of sections to the slide surface prior to 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 IEH, regulated under 21 CFR 864.3010, in the Pathology medical specialty. This device is exempt from GMP requirements.

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

Basic Information

Product Code
IEH
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