Technicon Chem 1 Plasma Glucose
FDA 510(k) K914794 · Heraeus Kulzer, Inc.
510(k) numberK914794
Submission
- Device name
- Technicon Chem 1 Plasma Glucose
- Applicant
- Heraeus Kulzer, Inc.
Tarrytown, NY, US - Received
- October 23, 1991
- Decision date
- December 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CFR – Hexokinase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | Roche Diagnostics | 02/12/2026SE |
| K252357 | Glucose2CFR · Traditional | Abbott Ireland | 10/24/2025SE |
| K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT…CFR · Traditional | Roche Diagnostics | 09/16/2022SE |
| K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsCFR · Traditional | Roche Diagnostics | 08/16/2019SE |
| K170316 | Alinity C Glucose Reagent Kit, Alinity C SystemCFR · Traditional | Abbott Laboratories | 10/19/2017SE |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…CFR · Traditional | Elitechgroup | 09/07/2016SE |
| K151487 | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase…CFR · Traditional | Diatron U.S., Inc. | 01/14/2016SE |
| K131189 | Unicel DXC Synchron Systems Glucose Reagent (Gluh)CFR · Traditional | Beckman Coulter, Inc. | 04/17/2014SE |
| K123018 | Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…CFR · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 04/23/2013SE |
| K120681 | Advia Chemistry GLUH_3 ReagentsCFR · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/15/2012SE |
More from Siemens Healthcare Diagnostics, Inc.
| 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 Chem 1 Plasma Glucose cleared by the FDA?
Technicon Chem 1 Plasma Glucose (K914794) received a 510(k) decision of Substantially Equivalent on December 18, 1991, 56 days after the submission was received.
What is the product code of K914794?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.