Binax Equate Glycohemoglobin
FDA 510(k) K874749 · Binax, Inc.
510(k) numberK874749
Submission
- Device name
- Binax Equate Glycohemoglobin
- Applicant
- Binax, Inc.
S. Portland, ME, US - Received
- November 18, 1987
- Decision date
- August 12, 1988
- 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 |
| 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 Binax Equate Glycohemoglobin cleared by the FDA?
Binax Equate Glycohemoglobin (K874749) received a 510(k) decision of Substantially Equivalent on August 12, 1988, 268 days after the submission was received.
What is the product code of K874749?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.