Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C Controls
FDA 510(k) K072686 · Axis-Shield Diagnostics, Ltd.
510(k) numberK072686
Submission
- Device name
- Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C Controls
- Applicant
- Axis-Shield Diagnostics, Ltd.
Dundee, GB - Received
- September 24, 2007
- Decision date
- March 17, 2008
- 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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| K180509 | Quo-Test A1c SystemLCP · Dual Track | Ekf-Diagnostic GmbH | 02/16/2019SE |
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| K170623 | ACE Hemoglobin A1c (HbA1c) ReagentLCP · Traditional | Alfa Wassermann Diagnostic Technologies, LLC | 02/27/2018SE |
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Questions and answers
When was Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C Controls cleared by the FDA?
Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C Controls (K072686) received a 510(k) decision of Substantially Equivalent on March 17, 2008, 175 days after the submission was received.
What is the product code of K072686?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.