Diazyme Glycated Serum Protein Poc Test Kit
FDA 510(k) K133803 · Diazyme Laboratories
510(k) numberK133803
Submission
- Device name
- Diazyme Glycated Serum Protein Poc Test Kit
- Applicant
- Diazyme Laboratories
Poway, CA, US - Received
- December 16, 2013
- Decision date
- August 6, 2014
- 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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Questions and answers
When was Diazyme Glycated Serum Protein Poc Test Kit cleared by the FDA?
Diazyme Glycated Serum Protein Poc Test Kit (K133803) received a 510(k) decision of Substantially Equivalent on August 6, 2014, 233 days after the submission was received.
What is the product code of K133803?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.