Technicon H* 3TM RTC System (In-Vitro Diag.Syst.)
FDA 510(k) K930685 · Heraeus Kulzer, Inc.
510(k) numberK930685
Submission
- Device name
- Technicon H* 3TM RTC System (In-Vitro Diag.Syst.)
- Applicant
- Heraeus Kulzer, Inc.
Tarrytown, NY, US - Received
- February 10, 1993
- Decision date
- June 22, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKL – Counter, Cell, Automated (Particle Counter)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5200
- Specialty
- Hematology
Other 510(k)s with product code GKL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152776 | Glocyte Automated Cell Counter SystemGKL · Traditional | Advanced Instruments, Inc. | 05/27/2016SE |
| K091539 | Iq 200 Urine Analizer Body Fluids ModuleGKL · Traditional | Iris Diagnostics | 08/31/2010SE |
| K071652 | Hemocue WBC SystemGKL · Traditional | Hemocue AB | 10/25/2007SE |
| K051693 | Modification to Bayer Advia 2120 Hematology Analyzer with Autoslide SystemGKL · Traditional | Bayer Healthcare, LLC | 12/07/2005SE |
| K050235 | Iq 200 Urine Analyzer Body Fluids ModuleGKL · Traditional | Iris International, Inc. | 03/23/2005SE |
| K032677 | Sysmex POCH-100IGKL · Traditional | Sysmex America, Inc. | 02/11/2004SE |
| K022331 | Advia 120 Hematology System, Cerebrospinal Fluid MethodGKL · Special | Bayer Diagnostics Corp. | 09/11/2002SE |
| K001683 | Sysmex R-500GKL · Traditional | Sysmex Corporation of America | 08/21/2000SE |
| K991070 | Coulter Z2 AnalyzerGKL · Traditional | Coulter Corp. | 05/11/1999SE |
| K981950 | Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional | Sysmex Corp. | 11/03/1998SE |
More from Sysmex Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K130647 | Xantasil Dynamix Fast Set Cartridge -2 X 380ML; Xantasil Fast Set Cartridge -6 X 50MLELW · Traditional | 05/17/2013SE |
| K123278 | Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch…KLE · Special | 12/07/2012SE |
| K120914 | Flexitime Fast & Scan Light FlowELW · Special | 07/25/2012SE |
| K113574 | Flexitime Monophase Pro ScanELW · Traditional | 07/13/2012SE |
| K112501 | Venus Pearl PLT Refill A1EBF · Traditional | 12/14/2011SE |
| K111832 | Paladon Ultra Powder (Pink), Paladon Ultra LiquidEBI · Traditional | 09/29/2011SE |
| K110037 | Palaxpress Ultra Powder (Pink); Palaxpress Ultra LiquidEBI · Traditional | 04/29/2011SE |
| K102770 | Flextime Fast & Scan Putty, Flextime Fast & Scan Light Flow, Flextime Fast & Scan Medium…ELW · Traditional | 12/21/2010SE |
| K101617 | Flexitime Xtreme 2 Heavy Tray Cartridge Refill, Fexitime Xtreme 2 Light Tray Cartridge…ELW · Traditional | 09/07/2010SE |
| K093575 | Gluma Desensitizer Power GelLBH · Traditional | 03/05/2010SE |
Questions and answers
When was Technicon H* 3TM RTC System (In-Vitro Diag.Syst.) cleared by the FDA?
Technicon H* 3TM RTC System (In-Vitro Diag.Syst.) (K930685) received a 510(k) decision of Substantially Equivalent on June 22, 1993, 132 days after the submission was received.
What is the product code of K930685?
The FDA product code is GKL – Counter, Cell, Automated (Particle Counter), a Class II (moderate risk) device regulated under 21 CFR 864.5200.