TISSUE PROCESSING SYSTEM
FDA 510(k) clearance K801513 · decided 1980-07-28
Clearance details
- K-number
- K801513
- Device name
- TISSUE PROCESSING SYSTEM
- Applicant
- Innovative Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-06-30
- Decision date
- 1980-07-28
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- IEO
- Device class
- 1
- Regulation number
- 864.3875
- 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 |
|---|---|---|
| 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 |
| SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR (K881165) | Sakura Finetek U.S.A., Inc. | 1988-07-01 |
| 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-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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SHARPX NEEDLE DESTRUCTION UNIT (P980015/S005) | Innovative Medical Systems, Inc. | 2002-06-12 |
| SHARPX NEEDLE DESTRUCTION UNIT (P980015/S004) | Innovative Medical Systems, Inc. | 2001-08-15 |
| SHARP(X)TM NEEDLE DESTRUCTION UNIT (P980015/S003) | Innovative Medical Systems, Inc. | 1999-09-17 |
| SHARP NEEDLE DESTRUCTION UNIT (P980015/S002) | Innovative Medical Systems, Inc. | 1999-03-19 |
| SHARP NEEDLE DESTRUCTION UNIT (P980015/S001) | Innovative Medical Systems, Inc. | 1998-12-14 |
| SHARPX (P980015) | Innovative Medical Systems, Inc. | 1998-08-06 |