Glycosylated Hemoglobin Assay; Clinical Chemistry
FDA 510(k) K120199 · Beckman Coulter, Inc.
510(k) numberK120199
Submission
- Device name
- Glycosylated Hemoglobin Assay; Clinical Chemistry
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- January 23, 2012
- Decision date
- October 12, 2012
- 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 Glycosylated Hemoglobin Assay; Clinical Chemistry cleared by the FDA?
Glycosylated Hemoglobin Assay; Clinical Chemistry (K120199) received a 510(k) decision of Substantially Equivalent on October 12, 2012, 263 days after the submission was received.
What is the product code of K120199?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.