LKB 2189 Ultroprocessor
FDA 510(k) K843506 · Lkb Instruments, Inc.
510(k) numberK843506
Submission
- Device name
- LKB 2189 Ultroprocessor
- Applicant
- Lkb Instruments, Inc.
Mchenry, IL, US - Received
- September 6, 1984
- Decision date
- November 30, 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 |
| 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 |
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| 510(k) | Device | Decision |
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| K874094 | 1205 Betaplate Liquid Scintillation CounterJJJ · Traditional | 11/04/1987SE |
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| K871599 | Delfia(Tm) Hige KitDHB · Traditional | 06/12/1987SE |
| K871644 | Delfia (TM) HTSH KitJLW · Traditional | 05/12/1987SE |
| K864452 | Delfia(Tm) Triiodothyronine (T3) KitCDP · Traditional | 02/02/1987SE |
| K864733 | LKB 2260 MacrotomeIDO · Traditional | 01/05/1987SE |
| K862848 | LKB Ultrobact (TM) Pneumococcus Kit; 2321-110GWC · Traditional | 12/18/1986SE |
| K863422 | Delfia(Tm) Cortisol KitJFT · Traditional | 09/26/1986SE |
| K862044 | Delfia (TM) HCG KitJHJ · Traditional | 07/11/1986SE |
Questions and answers
When was LKB 2189 Ultroprocessor cleared by the FDA?
LKB 2189 Ultroprocessor (K843506) received a 510(k) decision of Substantially Equivalent on November 30, 1984, 85 days after the submission was received.
What is the product code of K843506?
The FDA product code is IEO – Processor, Tissue, Automated, a Class I (low risk) device regulated under 21 CFR 864.3875.