Bio.Rad Hemoglobin A1 by Column Test
FDA 510(k) K811710 · Bio-Rad
510(k) numberK811710
Submission
- Device name
- Bio.Rad Hemoglobin A1 by Column Test
- Applicant
- Bio-Rad
Mchenry, IL, US - Received
- June 17, 1981
- Decision date
- July 15, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Bio.Rad Hemoglobin A1 by Column Test cleared by the FDA?
Bio.Rad Hemoglobin A1 by Column Test (K811710) received a 510(k) decision of Substantially Equivalent on July 15, 1981, 28 days after the submission was received.
What is the product code of K811710?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.