510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002199Substantially Equivalent

Modification to Liquid Glucose (Hexokinase) Reagent Set

Horiba Instruments Incorporated, Lincoln Park MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002199 is the FDA 510(k) clearance record for MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET, a class II device, cleared for Pointe Scientific, Inc., on under FDA product code CFR (Hexokinase, Glucose). FDA records list 89 510(k) clearances for HORIBA INSTRUMENTS INCORPORATED, from to . As of , FDA records show 14 recalls naming K002199.

Clearance record

Decision date
Received
(123 days to decision)
Product code
CFR Hexokinase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Pointe Scientific, Inc., 1025 John A. Papalas Dr., Lincoln Park MI
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