Autotechnicon V Tissue Process Sys
FDA 510(k) K834599 · Technicon Instruments Corp.
510(k) numberK834599
Submission
- Device name
- Autotechnicon V Tissue Process Sys
- Applicant
- Technicon Instruments Corp.
Mchenry, IL, US - Received
- December 30, 1983
- Decision date
- February 4, 1984
- 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 |
| K883599 | LX-80 Automated Tissue Processor (Plastic)IEO · Traditional | Innovative Medical Systems, Inc. | 09/02/1988SE |
| 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 |
| 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 |
|---|---|---|
| K914888 | Technicon Chem 1(TM) Syst (GEN2 Syst)CIX · Traditional | 11/27/1991SE |
| K914511 | Technicon Axon(Tm) System Methods Anyalye HDL CholLBS · Traditional | 11/27/1991SE |
| K914025 | Technicon Axon(Tm) Systems, Alt(P 5-P)/AST(P 5-P)CIT · Traditional | 11/22/1991SE |
| K912616 | Technicon Immuno 1 TM System Additional AnalytesKLI · Traditional | 09/25/1991SE |
| K912413 | Chem-Link Data Base ManagerJJQ · Traditional | 07/01/1991SE |
| K903825 | Drug of Abuse Analysis SystemDIS · Traditional | 09/27/1990SE |
| K903824 | Drug of Abuse Analysis System Free Radical AssayDKZ · Traditional | 09/27/1990SE |
| K903305 | Technicon Chem I System Carbon Dioxide MethodKHS · Traditional | 09/27/1990SE |
| K903306 | Technicon Chem I System Magnesium MethodJGJ · Traditional | 08/29/1990SE |
| K901410 | Technicon RA-2000(TM) SystemJJC · Traditional | 07/17/1990SE |
Questions and answers
When was Autotechnicon V Tissue Process Sys cleared by the FDA?
Autotechnicon V Tissue Process Sys (K834599) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 36 days after the submission was received.
What is the product code of K834599?
The FDA product code is IEO – Processor, Tissue, Automated, a Class I (low risk) device regulated under 21 CFR 864.3875.