SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR
FDA 510(k) clearance K881165 · decided 1988-07-01
Clearance details
- K-number
- K881165
- Device name
- SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR
- Applicant
- Sakura Finetek U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-20
- Decision date
- 1988-07-01
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- IEO
- Device class
- 1
- Regulation number
- 864.3875
- 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 |
|---|---|---|
| MICROWAVE AUTOMATED TISSUE PROCESSOR (K924590) | Innovative Medical Systems, Inc. | 1992-12-29 |
| LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) (K883599) | Innovative Medical Systems, Inc. | 1988-09-02 |
| LX 300 TISSUE PROCESSOR (K853938) | Innovative Medical Systems, Inc. | 1985-10-10 |
| LX120 TISSUE PROCESSOR (K851054) | Innovative Medical Systems, Inc. | 1985-05-15 |
| LKB 2189 ULTROPROCESSOR (K843506) | Lkb Instruments, Inc. | 1984-11-30 |
| AUTOTECHNICON V TISSUE PROCESS SYS (K834599) | Technicon Instruments Corp. | 1984-02-04 |
| TISSUE-TEK V.I.P. 100/200 (K831313) | Miles Laboratories, Inc. | 1983-07-28 |
| TISSUE-TEK III MINI-RAPID PROCESSOR (K801427) | Miles Laboratories, Inc. | 1980-07-28 |
| TISSUE PROCESSING SYSTEM (K801513) | Innovative Medical Systems, Inc. | 1980-07-28 |
| TISSUE-TEK III V.I.P. (K771308) | Miles Laboratories, Inc. | 1977-08-22 |
| HISTO-TEK W/ AUTOMATIC COVERSLIPPER (K761062) | Miles Laboratories, Inc. | 1977-03-07 |
Recalls involving this device
No recalls on record reference this clearance.