KIM · Device For Sealing Microsections
Pathology · 21 CFR 864.3400 · Class 1
Overview
| Product Code | KIM |
|---|---|
| Device Name | Device For Sealing Microsections |
| Regulation | 21 CFR 864.3400 |
| Device Class | Class 1 |
| Review Panel | Pathology |
Identification
A device for sealing microsections is an automated instrument used to seal stained cells and microsections for histological and cytological examination.
Classification Rationale
Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K780261 | COVERSLIPPER | Shandon, Inc. | Apr 18, 1978 | SESE |
Top Applicants
- Shandon, Inc. — 1 clearance
