Polyethylene Glycol (Carbowax)
Polyethylene Glycol (Carbowax) is a water-soluble polymer used in histopathology as an embedding medium alternative to paraffin and as a cryoprotectant, and is also used as a tissue-mounting medium for aqueous stains in frozen section preparations. 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 IER, regulated under 21 CFR 864.4010, in the Pathology medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- IER
- Device Class
- FDA class 1
- Regulation Number
- 864.4010
- 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 |
|---|---|---|---|---|
| K852045 | SED-FIX CONCENTRATE | Jun 10, 1985 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.