Table, Slide Warming
A slide warming table is a flat heated surface used in histopathology laboratories to dry and adhere tissue sections to glass slides after mounting, promoting section attachment and removing excess water before staining. 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 IEG, regulated under 21 CFR 864.3010, in the Pathology medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- IEG
- Device Class
- FDA class 1
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K812497 | IMMULIK STAIN PLATE | Sep 23, 1981 | Substantially Equivalent | Immulok, Inc. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.