510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924496Substantially Equivalent

Glycomat Green Hba2 Estimation Reagent Kit

Drew Scientific, Ltd., London W4 4ph Uk, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924496 is the FDA 510(k) clearance record for GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT, a class II device, cleared for Drew Scientific , Ltd. on under FDA product code JPD (Hemoglobin A2 Quantitation). FDA records list 9 510(k) clearances for Drew Scientific , Ltd., from to . As of , FDA records show no recalls naming K924496.

Clearance record

Decision date
Received
(73 days to decision)
Product code
JPD Hemoglobin A2 Quantitation
Regulation
21 CFR 864.7400
Device class
Class II
Review panel
Hematology
Applicant
Drew Scientific , Ltd. 12 Barley Mow Passage, London W4 4ph Uk, GB
510(k) summary
Statement
Third party review
No

Clearances, product code JPD

Trailing 12 months

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

FDA records show no clearances under product code JPD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JPD, 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