Randox Haemoglobin A1C
FDA 510(k) K021897 · Randox Laboratories, Ltd.
510(k) numberK021897
Submission
- Device name
- Randox Haemoglobin A1C
- Applicant
- Randox Laboratories, Ltd.
Crumlin, IE - Received
- June 10, 2002
- Decision date
- November 26, 2002
- 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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| K183230 | OneDraw A1C Test SystemLCP · Traditional | Drawbridge Health, Inc. | 08/15/2019SE |
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| 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 Randox Haemoglobin A1C cleared by the FDA?
Randox Haemoglobin A1C (K021897) received a 510(k) decision of Substantially Equivalent on November 26, 2002, 169 days after the submission was received.
What is the product code of K021897?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.