Fixative, Acid Containing
An acid-containing fixative is a pathology reagent used to preserve and harden biological tissue specimens obtained during biopsy or surgery, enabling histological processing and microscopic examination for diagnostic purposes. It is classified as FDA Class 1, the lowest risk tier, and is exempt from Good Manufacturing Practice (GMP) requirements, reflecting its low risk profile. The product code is LDW, regulated under 21 CFR 864.4010, in the Pathology specialty. No premarket notification is required.
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Basic Information
- Product Code
- LDW
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K883062 | ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID | Aug 04, 1988 | Substantially Equivalent | Alpha-Tec Systems, Inc. |
| K842923 | PICRIC ACID 1% W/V | Sep 11, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K842922 | PICRIC ACID SATURATED SOLUTION | Sep 07, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K831058 | SAF FIXATIVE | Jun 08, 1983 | Substantially Equivalent | American Micro Scan |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.