510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980026Substantially Equivalent

Glucose (Hk) - Incorporating Dynamic Stabilization Technology - (Dst)

Trace America, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980026 is the FDA 510(k) clearance record for GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST), a class II device, cleared for Trace America, Inc. on under FDA product code CFR (Hexokinase, Glucose). FDA records list 22 510(k) clearances for Trace America, Inc., from to . As of , FDA records show no recalls naming K980026.

Clearance record

Decision date
Received
(64 days to decision)
Product code
CFR Hexokinase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Trace America, Inc. 7260 NW 58th St., Miami FL
510(k) summary
Statement
Third party review
No

Clearances, product code CFR

Trailing 12 months
1 clearance under product code CFR in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CFR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260