Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High Control
FDA 510(k) K000239 · Genzyme Corp.
510(k) numberK000239
Submission
- Device name
- Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High Control
- Applicant
- Genzyme Corp.
Cambridge, MA, US - Received
- January 27, 2000
- Decision date
- March 21, 2000
- 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 Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High Control cleared by the FDA?
Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High Control (K000239) received a 510(k) decision of Substantially Equivalent on March 21, 2000, 54 days after the submission was received.
What is the product code of K000239?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.