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
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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
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Summary Malfunction Reporting