KDX
8 FDA 510(k) clearances · Product code
28 daysmedian time to decision
34 days90th percentile
8clearances measured
FDA profile
- Official device name
- Solution, Decalcifier, Acid Containing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.4010
- Medical specialty
- Pathology
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DECALCIFYING SOLUTION (K872625) | Stephens Scientific | 1987-08-06 |
| SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E (K850636) | Fisher Scientific Co., LLC | 1985-03-20 |
| DECALCIFIER SOLUTION (K842726) | E K Ind., Inc. | 1984-08-03 |
| DECALCIFIER I (K841488) | Surgipath Medical Industries, Inc. | 1984-05-02 |
| VOLU-SOL DECALCIFER (K822036) | Volu Sol Medical Industries | 1982-08-03 |
| FORMICAL (K821443) | Lerner Laboratories, Inc. | 1982-06-02 |
| CAL-RITE (K811801) | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
| DECALCIFIER II (K810836) | Surgipath | 1981-04-23 |
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Every clearance here is in the API, with alerts when new ones post.