Dilulab 230
FDA 510(k) K823522 · Innovative Medical Systems, Inc.
510(k) numberK823522
Submission
- Device name
- Dilulab 230
- Applicant
- Innovative Medical Systems, Inc.
Mchenry, IL, US - Received
- November 29, 1982
- Decision date
- December 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKH – Apparatus, Automated Blood Cell Diluting
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.5240
- Specialty
- Hematology
Other 510(k)s with product code GKH
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|---|---|---|---|
| K100684 | Celltracks Autoprep System MODEL:9541GKH · Traditional | Veridex, LLC | 08/26/2010SE |
| K040077 | Immunicon Celltracks Autoprep SystemGKH · Traditional | Immunicon Corp. | 03/12/2004SE |
| K022512 | Cellprep Sample Preparation System, Model 9518GKH · Traditional | Immunicon Corp. | 09/30/2002SE |
| K021150 | Coulter CellprepGKH · Traditional | Beckman Coulter, Inc. | 06/11/2002SE |
| K935953 | Coulter Multi Q PrepGKH · Traditional | Coulter Corp. | 03/11/1994SE |
| K923530 | Coulter Multi-Q-PrepGKH · Traditional | Coulter Electronics, Inc. | 10/14/1992SE |
| K904795 | Facsprep Robotic Sample Preparation SystemGKH · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/31/1990SE |
| K882767 | Sysmex DD-100 Whole Blood Dilution SystemGKH · Traditional | Toa Medical Electronics USA, Inc. | 07/18/1988SE |
| K852373 | AD150, Automated Hematology DilutorGKH · Traditional | Abbott Diagnostics | 07/05/1985SE |
| K842747 | Hycel Dilutor, Various Models/MultiGKH · Traditional | R&D Systems, Inc. | 10/01/1984SE |
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| 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 |
| K883599 | LX-80 Automated Tissue Processor (Plastic)IEO · Traditional | 09/02/1988SE |
| K880745 | LX-100 Slide StainerKPA · Traditional | 04/27/1988SE |
Questions and answers
When was Dilulab 230 cleared by the FDA?
Dilulab 230 (K823522) received a 510(k) decision of Substantially Equivalent on December 28, 1982, 29 days after the submission was received.
What is the product code of K823522?
The FDA product code is GKH – Apparatus, Automated Blood Cell Diluting, a Class I (low risk) device regulated under 21 CFR 864.5240.