510(k) K801513
- Device
- TISSUE PROCESSING SYSTEM
- Applicant
- INNOVATIVE MEDICAL SYSTEMS, INC.
- 510(k) number
- K801513
- Product code
- IEO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-07-28
- Date received
- 1980-06-30
- Regulation
- 864.3875
- Classification name
- Processor, Tissue, Automated
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3009155756
- 3010611944
- 3003584784
- 1063851
- 3043606682
- 8010478
- 2083544
- 2432235
- 3031915160
- 1000303355
- 9680927
- 2954792
- 3038188821
- 3004594181
- 3010692993
- 3014165737
- 3010889707
- 3015167933
- 1000391282
- 1036362
- 3003639866
- 3010889828
- 3038196622
- 3008399755
- 3008776165
- 3009034535
- 3006610913
- 3018771894
- 8020030
- 3010685493
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IEO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883599 | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | Innovative Medical Systems, Inc. | 1988-09-02 |
| K881165 | SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR | Sakura Finetek U.S.A., Inc. | 1988-07-01 |
| K853938 | LX 300 TISSUE PROCESSOR | Innovative Medical Systems, Inc. | 1985-10-10 |
| K851054 | LX120 TISSUE PROCESSOR | Innovative Medical Systems, Inc. | 1985-05-15 |
| K843506 | LKB 2189 ULTROPROCESSOR | Lkb Instruments, Inc. | 1984-11-30 |
| K834599 | AUTOTECHNICON V TISSUE PROCESS SYS | Technicon Instruments Corp. | 1984-02-04 |
| K831313 | TISSUE-TEK V.I.P. 100/200 | Miles Laboratories, Inc. | 1983-07-28 |
| K801427 | TISSUE-TEK III MINI-RAPID PROCESSOR | Miles Laboratories, Inc. | 1980-07-28 |
| K771308 | TISSUE-TEK III V.I.P. | Miles Laboratories, Inc. | 1977-08-22 |
| K761062 | HISTO-TEK W/ AUTOMATIC COVERSLIPPER | Miles Laboratories, Inc. | 1977-03-07 |
Legacy Summary#
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FDA Review#
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