Glucose(Hexokinase) Reagent Set
FDA 510(k) K844998 · Sterling Biochemical, Inc.
510(k) numberK844998
Submission
- Device name
- Glucose(Hexokinase) Reagent Set
- Applicant
- Sterling Biochemical, Inc.
Dearborn, MI, US - Received
- December 26, 1984
- Decision date
- January 18, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K844251 | Alt/Gpt Reagent SetCKA · Traditional | 01/08/1985SE |
| K843332 | Alkaline Phosphatase Reagent SetCJE · Traditional | 09/14/1984SE |
| K842521 | Ast/Got Reagent Set UV RateCIT · Traditional | 08/12/1984SE |
| K840064 | Urea Nitrogen Reagent SetCDQ · Traditional | 06/14/1984SE |
| K834084 | Hydroxybutyrate Dehydrogenase ReagentJKF · Traditional | 02/04/1984SE |
| K834045 | Uric Acid Reagent SetKNK · Traditional | 01/30/1984SE |
| K833864 | Amylase Reagent Set-Modified CarawayCJA · Traditional | 01/13/1984SE |
| K833062 | Serum Cholinesterase Reagent SetDLI · Traditional | 11/25/1983SE |
| K831874 | Lipase Reagent SetJGX · Traditional | 08/12/1983SE |
| K831415 | Lactic Dehydrogenase Reagent SetCFJ · Traditional | 06/16/1983SE |
Questions and answers
When was Glucose(Hexokinase) Reagent Set cleared by the FDA?
Glucose(Hexokinase) Reagent Set (K844998) received a 510(k) decision of Substantially Equivalent on January 18, 1985, 23 days after the submission was received.
What is the product code of K844998?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.