KDX — Solution, Decalcifier, Acid Containing Class I
FDA product code KDX covers "Solution, Decalcifier, Acid Containing", a Class I medical device regulated under 21 CFR 864.4010. Submissions are reviewed by the Pathology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KDX
- Device Class
- Class I
- Regulation Number
- 864.4010
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K872625 | stephens scientific | DECALCIFYING SOLUTION | August 6, 1987 |
| K850636 | fisher scientific co | SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E | March 20, 1985 |
| K842726 | e k ind | DECALCIFIER SOLUTION | August 3, 1984 |
| K841488 | surgipath medical industries | DECALCIFIER I | May 2, 1984 |
| K822036 | volu sol medical industries | VOLU-SOL DECALCIFER | August 3, 1982 |
| K821443 | lerner laboratories | FORMICAL | June 2, 1982 |
| K811801 | richard-allan medical ind | CAL-RITE | July 28, 1981 |
| K810836 | surgipath | DECALCIFIER II | April 23, 1981 |