LX-80 Automated Tissue Processor (Plastic)
FDA 510(k) K883599 · Innovative Medical Systems, Inc.
510(k) numberK883599
Submission
- Device name
- LX-80 Automated Tissue Processor (Plastic)
- Applicant
- Innovative Medical Systems, Inc.
Ivyland, PA, US - Received
- August 23, 1988
- Decision date
- September 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IEO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924590 | Microwave Automated Tissue ProcessorIEO · Traditional | Innovative Medical Systems, Inc. | 12/29/1992SE |
| K881165 | Sakura HEM-480 Electron Microscopy ProcessorIEO · Traditional | Sakura Finetek U.S.A., Inc. | 07/01/1988SE |
| K853938 | LX 300 Tissue ProcessorIEO · Traditional | Innovative Medical Systems, Inc. | 10/10/1985SE |
| K851054 | LX120 Tissue ProcessorIEO · Traditional | Innovative Medical Systems, Inc. | 05/15/1985SE |
| K843506 | LKB 2189 UltroprocessorIEO · Traditional | Lkb Instruments, Inc. | 11/30/1984SE |
| K834599 | Autotechnicon V Tissue Process SysIEO · Traditional | Technicon Instruments Corp. | 02/04/1984SE |
| K831313 | Tissue-Tek V.I.P. 100/200IEO · Traditional | Miles Laboratories, Inc. | 07/28/1983SE |
| K801513 | Tissue Processing SystemIEO · Traditional | Innovative Medical Systems, Inc. | 07/28/1980SE |
| K801427 | Tissue-Tek III Mini-Rapid ProcessorIEO · Traditional | Miles Laboratories, Inc. | 07/28/1980SE |
| K771308 | Tissue-Tek III V.I.P.IEO · Traditional | Miles Laboratories, Inc. | 08/22/1977SE |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973035 | Viola II Dental Camera SystemEIA · Traditional | 09/24/1997SE |
| K951469 | Bazooka SystemFNM · Traditional | 06/28/1995SE |
| K933184 | Positive Airway Pressure SystemBZD · Traditional | 11/28/1994SE |
| K924590 | Microwave Automated Tissue ProcessorIEO · Traditional | 12/29/1992SE |
| K922081 | Labotech Automated Microtiter AnalyzerJJQ · Traditional | 09/02/1992SE |
| K921005 | AutoloaderJQW · Traditional | 04/29/1992SE |
| K915457 | Phaco 20/20 System IHQC · Traditional | 02/24/1992SE |
| K915456 | Phaco 3000 LinearHQC · Traditional | 02/12/1992SE |
| K880745 | LX-100 Slide StainerKPA · Traditional | 04/27/1988SE |
| K853938 | LX 300 Tissue ProcessorIEO · Traditional | 10/10/1985SE |
Questions and answers
When was LX-80 Automated Tissue Processor (Plastic) cleared by the FDA?
LX-80 Automated Tissue Processor (Plastic) (K883599) received a 510(k) decision of Substantially Equivalent on September 2, 1988, 10 days after the submission was received.
What is the product code of K883599?
The FDA product code is IEO – Processor, Tissue, Automated, a Class I (low risk) device regulated under 21 CFR 864.3875.