510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963909Substantially Equivalent

Hemocue Glucolin

Direct Solutions, Westford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963909 is the FDA 510(k) clearance record for HEMOCUE GLUCOLIN, a class I device, cleared for Direct Solutions on under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)). FDA records list 5 510(k) clearances for Direct Solutions, from to . As of , FDA records show no recalls naming K963909.

Clearance record

Decision date
Received
(39 days to decision)
Product code
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Direct Solutions 7 Hayrick Ln., Westford MA
510(k) summary
Statement
Third party review
No

Clearances, product code JJX

Trailing 12 months

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

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