Solution, Carnoy'S
Carnoy's Solution is a rapid-acting tissue fixative used in pathology and histology laboratories, composed of ethanol, chloroform, and acetic acid, and valued for its ability to quickly penetrate and preserve tissue while also acting as a decalcifying agent for bone specimens. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IGM, regulated under 21 CFR 864.4010, within the Pathology medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.
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Basic Information
- Product Code
- IGM
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K842737 | CARNOY'S SOLUTION | Sep 07, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K822126 | VOLU-SOL CARNOY FLUID | Aug 05, 1982 | Substantially Equivalent | Volu Sol Medical Industries |
| K790815 | CULTURETTE BRAND PVA | May 15, 1979 | Substantially Equivalent | Marion Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.