Solution, Decalcifier, Acid Containing
An acid-containing decalcifier solution is a laboratory reagent used in histopathology to remove calcium mineral deposits from fixed bone or calcified tissue specimens, rendering them soft enough for sectioning on a microtome for microscopic examination. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls. Product code KDX is regulated under 21 CFR 864.4010 in the Pathology medical specialty. This device is GMP exempt, meaning it is not subject to full Quality System Regulation requirements.
Research product code KDX in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- KDX
- 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 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K872625 | DECALCIFYING SOLUTION | Aug 06, 1987 | Substantially Equivalent | Stephens Scientific |
| K850636 | SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E | Mar 20, 1985 | Substantially Equivalent | Fisher Scientific Co., LLC |
| K842726 | DECALCIFIER SOLUTION | Aug 03, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K841488 | DECALCIFIER I | May 02, 1984 | Substantially Equivalent | Surgipath Medical Industries, Inc. |
| K822036 | VOLU-SOL DECALCIFER | Aug 03, 1982 | Substantially Equivalent | Volu Sol Medical Industries |
| K821443 | FORMICAL | Jun 02, 1982 | Substantially Equivalent | Lerner Laboratories, Inc. |
| K811801 | CAL-RITE | Jul 28, 1981 | Substantially Equivalent | Richard-Allan Medical Ind., Inc. |
| K810836 | DECALCIFIER II | Apr 23, 1981 | Substantially Equivalent | Surgipath |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.