Eclipse Ica Glucose
FDA 510(k) K905144 · Biotope, Inc.
510(k) numberK905144
Submission
- Device name
- Eclipse Ica Glucose
- Applicant
- Biotope, Inc.
Redmond, WA, US - Received
- November 15, 1990
- Decision date
- January 4, 1991
- 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
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 |
|---|---|---|
| K905145 | Eclipse Ica CholesterolCHH · Traditional | 02/26/1991SE |
| K910302 | Eclipse Ica AnalyzerJJQ · Traditional | 02/22/1991SE |
| K910256 | Eclipse Ica TSHJLW · Traditional | 02/22/1991SE |
| K905719 | Eclipse Ica DigoxinDPO · Traditional | 01/17/1991SE |
| K905601 | Eclipse Ica TriglyceridesCDT · Traditional | 01/17/1991SE |
| K905602 | Eclipse Ica BunCDQ · Traditional | 01/16/1991SE |
Questions and answers
When was Eclipse Ica Glucose cleared by the FDA?
Eclipse Ica Glucose (K905144) received a 510(k) decision of Substantially Equivalent on January 4, 1991, 50 days after the submission was received.
What is the product code of K905144?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.