Glucose-Sl Assay, Catalogue No. 235-60
FDA 510(k) K961282 · Diagnostic Chemicals , Ltd.
510(k) numberK961282
Submission
- Device name
- Glucose-Sl Assay, Catalogue No. 235-60
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E.I., CA - Received
- April 3, 1996
- Decision date
- June 21, 1996
- 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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| K220134 | cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT…CFR · Traditional | Roche Diagnostics | 09/16/2022SE |
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| 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 |
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| K060139 | Crp-Advance Assay, Models 250-20, 250-25DCK · Traditional | 04/28/2006SE |
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| K051191 | DCL Microalbumin Assay, Model 252-20DCF · Traditional | 07/05/2005SE |
| K042330 | Acetaminophen-Sl AssayLDP · Traditional | 01/07/2005SE |
| K042362 | Modification to Carbon DIOXIDE-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and…KHS · Traditional | 12/27/2004SE |
| K042329 | Salicylate-Sl AssayDKJ · Traditional | 12/27/2004SE |
| K041928 | Hdl-Advance Assay, Cat. No. 278-20, 278-50A, 278-50BLBS · Traditional | 11/23/2004SE |
Questions and answers
When was Glucose-Sl Assay, Catalogue No. 235-60 cleared by the FDA?
Glucose-Sl Assay, Catalogue No. 235-60 (K961282) received a 510(k) decision of Substantially Equivalent on June 21, 1996, 79 days after the submission was received.
What is the product code of K961282?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.