510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000239Substantially Equivalent

Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High Control

Genzyme Corporation, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000239 is the FDA 510(k) clearance record for GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL, a class II device, cleared for Genzyme Corp. on under FDA product code LCP (Assay, Glycosylated Hemoglobin). FDA records list 33 510(k) clearances for Genzyme Corp., from to . As of , FDA records show no recalls naming K000239.

Clearance record

Decision date
Received
(54 days to decision)
Product code
LCP Assay, Glycosylated Hemoglobin
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Genzyme Corp. 500 Kendall St., Cambridge MA
510(k) summary
Summary
Third party review
No

Clearances, product code LCP

Trailing 12 months

FDA records hold no clearances under product code LCP in the trailing twelve months.

FDA records show no clearances under product code LCP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260