Focus-Ghb
FDA 510(k) K871679 · Awareness Technology, Inc.
510(k) numberK871679
Submission
- Device name
- Focus-Ghb
- Applicant
- Awareness Technology, Inc.
Palm City, FL, US - Received
- April 29, 1987
- Decision date
- July 28, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7470
- Specialty
- Hematology
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|---|---|---|---|
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro AnalyzerLCP · Dual Track | Nova Biomedical Corporation | 11/22/2024SE |
| K231465 | Q-Pad Test SystemLCP · Traditional | Qurasense | 12/06/2023SE |
| K214117 | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 AnalyzerLCP · Dual Track | Abbott Diagnostics Technologies AS | 09/27/2023SE |
| K192987 | Aina HbA1c Monitoring System 2LCP · Traditional | Jana Care, Inc. | 03/26/2020SE |
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP · Traditional | Ixensor Co, Ltd. | 10/29/2019SE |
| K183230 | OneDraw A1C Test SystemLCP · Traditional | Drawbridge Health, Inc. | 08/15/2019SE |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP · Traditional | Ixensor Co, Ltd. | 04/12/2019SE |
| K180509 | Quo-Test A1c SystemLCP · Dual Track | Ekf-Diagnostic GmbH | 02/16/2019SE |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent…LCP · Traditional | Skyla Corporation H.S.P.B | 09/25/2018SE |
| K170623 | ACE Hemoglobin A1c (HbA1c) ReagentLCP · Traditional | Alfa Wassermann Diagnostic Technologies, LLC | 02/27/2018SE |
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| K013420 | Chemwell, Also Known AS Project 2900JLW · Abbreviated | 07/19/2002SE |
| K010877 | Chemwell, Model 2900CIX · Abbreviated | 05/23/2001SE |
| K974762 | Stat TracksJJQ · Traditional | 01/28/1998SE |
| K943729 | Dye Check Strips 545-630JJY · Traditional | 12/29/1994SE |
| K941394 | Stat Fax 2600JQW · Traditional | 06/03/1994SE |
| K923598 | Redi-Check Photmeter Q.A.JFS · Traditional | 10/14/1992SE |
| K900224 | Stat FAX(TM)-2100JJQ · Traditional | 03/01/1990SE |
| K892656 | Dri-Dye Check Strips (TM)-405JJX · Traditional | 05/22/1989SE |
| K882938 | Stat Fax(Tm)JJQ · Traditional | 09/09/1988SE |
Questions and answers
When was Focus-Ghb cleared by the FDA?
Focus-Ghb (K871679) received a 510(k) decision of Substantially Equivalent on July 28, 1987, 90 days after the submission was received.
What is the product code of K871679?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.