510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K880242Substantially Equivalent

Kone Calcium Test

The Rupp & Bowman Co., Irving TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880242 is the FDA 510(k) clearance record for KONE CALCIUM TEST, a class II device, cleared for The Rupp & Bowman Co. on under FDA product code CJY (Azo Dye, Calcium). FDA records list 3 510(k) clearances for The Rupp & Bowman Co., from to . As of , FDA records show no recalls naming K880242.

Clearance record

Decision date
Received
(55 days to decision)
Product code
CJY Azo Dye, Calcium
Regulation
21 CFR 862.1145
Device class
Class II
Review panel
Clinical Chemistry
Applicant
The Rupp & Bowman Co. 9206 Royal Ln., Irving TX
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