SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER
FDA 510(k) clearance K882881 · decided 1988-07-28
Clearance details
- K-number
- K882881
- Device name
- SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER
- Applicant
- Sakura Finetek U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-11
- Decision date
- 1988-07-28
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- KES
- Device class
- 1
- Regulation number
- 864.3010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Torrance, CA, 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 |
|---|---|---|
| MICROSCOPE COVER GLASSES (K872874) | Abco Dealers, Inc. | 1987-08-10 |
| KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP (K771925) | Harleco | 1977-11-02 |
Recalls involving this device
No recalls on record reference this clearance.