Gelatin For Specimen Adhesion
Gelatin for Specimen Adhesion is a reagent used in pathology and histology laboratories to coat glass slides and improve the adhesion of tissue sections during staining and microscopic examination. 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 IFZ, 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
- IFZ
- 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 |
|---|---|---|---|---|
| K881659 | TISSUE SECTION ADHESIVE | Apr 21, 1988 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.