FORMICAL
FDA 510(k) clearance K821443 · decided 1982-06-02
Clearance details
- K-number
- K821443
- Device name
- FORMICAL
- Applicant
- Lerner Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-14
- Decision date
- 1982-06-02
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- KDX
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| CAL-RITE (K811801) | Richard-Allan Medical Ind., Inc. | 1981-07-28 |
| DECALCIFIER II (K810836) | Surgipath | 1981-04-23 |
Recalls involving this device
No recalls on record reference this clearance.