Multigent Hemoglobin A1C (Reagents), HB A1C Calibrators and HB A1C Controls
FDA 510(k) K033674 · Seradyn, Inc.
510(k) numberK033674
Submission
- Device name
- Multigent Hemoglobin A1C (Reagents), HB A1C Calibrators and HB A1C Controls
- Applicant
- Seradyn, Inc.
Indianapolis, IN, US - Received
- November 24, 2003
- Decision date
- February 9, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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|---|---|---|---|
| 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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| K070645 | Seradyn QMS TopiramateNWM · Traditional | 05/17/2007SE |
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| K062204 | Architect Cortisol AssayJFT · Traditional | 09/22/2006SE |
| K060998 | QMS TobramycinLCR · Traditional | 07/21/2006SE |
| K060709 | Multigent GentamicinLCD · Traditional | 06/15/2006SE |
| K052826 | QMS Quinidine. QMS Quinidine CalibratorsLBZ · Traditional | 12/23/2005SE |
| K051211 | QMS Zonisamide Reagents, Calibrators and ControlsNWM · Traditional | 11/18/2005SE |
| K052815 | QMS Amikacin ReagentsKLQ · Traditional | 11/01/2005SE |
| K050419 | QMS VancomycinLEH · Traditional | 04/01/2005SE |
| K042307 | Architect T-Uptake Calibrators (A-F) and Controls (Low, High)JIT · Abbreviated | 11/03/2004SE |
Questions and answers
When was Multigent Hemoglobin A1C (Reagents), HB A1C Calibrators and HB A1C Controls cleared by the FDA?
Multigent Hemoglobin A1C (Reagents), HB A1C Calibrators and HB A1C Controls (K033674) received a 510(k) decision of Substantially Equivalent on February 9, 2004, 77 days after the submission was received.
What is the product code of K033674?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.