510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K023396Substantially Equivalent

Amylase Eps-G7 (Liquid) Reagent Set, (Hitachi Analyzers)

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

K023396 is the FDA 510(k) clearance record for AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS), a class II device, cleared for Pointe Scientific, Inc., on under FDA product code CIJ (Saccharogenic, Amylase). FDA records list 89 510(k) clearances for HORIBA INSTRUMENTS INCORPORATED, from to . As of , FDA records show no recalls naming K023396.

Clearance record

Decision date
Received
(75 days to decision)
Product code
CIJ Saccharogenic, Amylase
Regulation
21 CFR 862.1070
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 CIJ

Trailing 12 months

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

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