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
K833072Substantially Equivalent

Technicon Ra-1000 Sys-Ise Module &

Technicon Instruments Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833072 is the FDA 510(k) clearance record for TECHNICON RA-1000 SYS-ISE MODULE &, a class II device, cleared for Technicon Instruments Corp. on under FDA product code JGS (Electrode, Ion Specific, Sodium). FDA records list 157 510(k) clearances for Technicon Instruments Corp., from to . As of , FDA records show no recalls naming K833072.

Clearance record

Decision date
Received
(67 days to decision)
Product code
JGS Electrode, Ion Specific, Sodium
Regulation
21 CFR 862.1665
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Technicon Instruments Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JGS

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