Olympus HBA1C Reagent, (Catalog Number OSR6192), Olympus HBA1C Calibrator, (Catolog Number ODC3032)
FDA 510(k) K031380 · Olympus America, Inc.
510(k) numberK031380
Submission
- Device name
- Olympus HBA1C Reagent, (Catalog Number OSR6192), Olympus HBA1C Calibrator, (Catolog Number ODC3032)
- Applicant
- Olympus America, Inc.
Irving, TX, US - Received
- May 1, 2003
- Decision date
- November 14, 2003
- 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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| 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 |
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| 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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Questions and answers
When was Olympus HBA1C Reagent, (Catalog Number OSR6192), Olympus HBA1C Calibrator, (Catolog Number ODC3032) cleared by the FDA?
Olympus HBA1C Reagent, (Catalog Number OSR6192), Olympus HBA1C Calibrator, (Catolog Number ODC3032) (K031380) received a 510(k) decision of Substantially Equivalent on November 14, 2003, 197 days after the submission was received.
What is the product code of K031380?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.