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
K191396Substantially Equivalent

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe

Horiba Abx SAS, Montpellier Cedex 4, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191396 is the FDA 510(k) clearance record for Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe, a class II device, cleared for HORIBA ABX SAS on under FDA product code CJY (Azo Dye, Calcium). FDA records list 17 510(k) clearances for HORIBA ABX SAS, from to . As of , FDA records show no recalls naming K191396.

Clearance record

Decision date
Received
(63 days to decision)
Product code
CJY Azo Dye, Calcium
Regulation
21 CFR 862.1145
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Horiba Abx Sas Parc Euromedecine, Rue Du Caducee – Bp7290, Montpellier Cedex 4, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CJY

Trailing 12 months

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

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