Direct HBA1C, Fructosamine, Glucose Oxidase Liquid
FDA 510(k) K080618 · Jas Diagnostics, Inc.
510(k) numberK080618
Submission
- Device name
- Direct HBA1C, Fructosamine, Glucose Oxidase Liquid
- Applicant
- Jas Diagnostics, Inc.
Miami, FL, US - Received
- March 5, 2008
- Decision date
- May 23, 2008
- 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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Questions and answers
When was Direct HBA1C, Fructosamine, Glucose Oxidase Liquid cleared by the FDA?
Direct HBA1C, Fructosamine, Glucose Oxidase Liquid (K080618) received a 510(k) decision of Substantially Equivalent on May 23, 2008, 79 days after the submission was received.
What is the product code of K080618?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.