Glycomat Haemoglobin Analyser
FDA 510(k) K920198 · Drew Scientific , Ltd.
510(k) numberK920198
Submission
- Device name
- Glycomat Haemoglobin Analyser
- Applicant
- Drew Scientific , Ltd.
London W4 4ph Uk, GB - Received
- January 15, 1992
- Decision date
- July 21, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Alfa Wassermann Diagnostic Technologies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K071562 | D3 Hematology Analyzer, Model D3GKZ · Traditional | 12/11/2007SE |
| K070704 | Trilogy AnalyzerCGA · Traditional | 07/13/2007SE |
| K060510 | Drew Scientific Glycated Hemoglobin Five Level Linearity KitJJX · Traditional | 06/19/2006SE |
| K043378 | Drew Scientific Ltd. Glycated Haemoglobin Two Level Calibrator KitJIT · Abbreviated | 12/29/2004SE |
| K012152 | DS30 Hcy Blood Collection TubesGIM · Traditional | 09/18/2001SE |
| K982003 | DS30 Hcy Homocysteine Assay KitLPS · Traditional | 02/11/1999SE |
| K933287 | 745 GlycomatLCP · Traditional | 09/09/1993SE |
| K924496 | Glycomat Green HBA2 Estimation Reagent KitJPD · Traditional | 11/16/1992SE |
Questions and answers
When was Glycomat Haemoglobin Analyser cleared by the FDA?
Glycomat Haemoglobin Analyser (K920198) received a 510(k) decision of Substantially Equivalent on July 21, 1992, 188 days after the submission was received.
What is the product code of K920198?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.