Raichem Glucose UV (Liquid)
FDA 510(k) K041052 · Hemagen Diagnostics, Inc.
510(k) numberK041052
Submission
- Device name
- Raichem Glucose UV (Liquid)
- Applicant
- Hemagen Diagnostics, Inc.
Columbia, MD, US - Received
- April 19, 2004
- Decision date
- June 30, 2004
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K041051 | Raichem Bun Rate Reagent (Liquid)CDQ · Traditional | 06/30/2004SE |
| K041009 | Raichem Calcium (Ocpc) Liquid ReagentCIC · Traditional | 06/25/2004SE |
| K031101 | Raichem Assayed Control Serum Level 1 & 2JJY · Abbreviated | 06/16/2003SE |
| K023784 | Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerLBR · Special | 12/24/2002SE |
| K022772 | Raichem Ldl-Cholesterol Direct ReagentMRR · Traditional | 09/17/2002SE |
| K022767 | Raichem Lipid CalibratorJIX · Special | 09/03/2002SE |
| K021194 | Raichem CRP High Sensitivity Test SystemDCK · Traditional | 07/29/2002SE |
| K022049 | Modification to Raichem Calcium ReagentCJY · Special | 07/19/2002SE |
| K012668 | Raichem Glucose UV ReagentCFR · Traditional | 10/15/2001SE |
| K012649 | Raichem Bun Rate ReagentCDQ · Traditional | 10/15/2001SE |
Questions and answers
When was Raichem Glucose UV (Liquid) cleared by the FDA?
Raichem Glucose UV (Liquid) (K041052) received a 510(k) decision of Substantially Equivalent on June 30, 2004, 72 days after the submission was received.
What is the product code of K041052?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.