Formaldehyde (Formalin, Formol)
Formaldehyde (also known as Formalin or Formol) is the most widely used tissue fixative in pathology laboratories, employed to preserve and cross-link proteins in biological specimens prior to histological processing, 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 IGG, 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
- IGG
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K882268 | ZINC FORMALIN CONCENTRATE | Jun 15, 1988 | Substantially Equivalent | Anatech, Ltd. |
| K861201 | FORMALDEHYDE SOLUTION, 37% | Apr 11, 1986 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
| K811794 | 37% FORMALDEHYDE | Jul 28, 1981 | Substantially Equivalent | Richard-Allan Medical Ind., Inc. |
| K802506 | PLEASCENT OR FORMA-SCENT | Nov 12, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792707 | PARA-PAK SAF | Jan 21, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K792705 | PARA-PAK FORMALIN | Jan 21, 1980 | Substantially Equivalent | Meridian Diagnostics, Inc. |
| K771201 | FORMALIN BUFFER CONCENTRATE | Aug 22, 1977 | Substantially Equivalent | Central Labs. Assoc. MD Pathologists |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.