CLEARIUM, MOUNTING MEDIUM
FDA 510(k) clearance K830659 · decided 1983-03-17
Clearance details
- K-number
- K830659
- Device name
- CLEARIUM, MOUNTING MEDIUM
- Applicant
- Surgipath Medical Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-02
- Decision date
- 1983-03-17
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- KEP
- 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 |
|---|---|---|
| ACRYTOL, MOUNTING MEDIUM (K810323) | Surgipath | 1981-03-06 |
| ENTELLAN (K800847) | Mcb Manufacturing Chemists, Inc. | 1980-05-08 |
Recalls involving this device
No recalls on record reference this clearance.