Formalin-Saline
Formalin-Saline is a buffered tissue fixative used in pathology laboratories to preserve biological specimens for histological staining and microscopic examination. This formulation combines formaldehyde with saline to create an isotonic fixative that minimizes osmotic damage to tissue structures. 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 IGC, 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
- IGC
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.