Solution, Formalin-Alcohol-Acetic Acid
Formalin-Alcohol-Acetic Acid Solution, also known as FAA fixative, is a compound tissue fixative used in pathology and histology laboratories combining the preservative actions of formalin, alcohol, and acetic acid to fix and harden tissue specimens for sectioning and microscopic analysis. 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 IGF, 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
- IGF
- 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 |
|---|---|---|---|---|
| K842731 | FORMALIN-ACETO-ALCOHOL FIXATIVE | Sep 11, 1984 | Substantially Equivalent | E K Ind., Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.