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
K983416Substantially Equivalent

Roche Diagnostics Magnesium Reagent, Cat# 1551353

Boehringer Mannheim Corp., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983416 is the FDA 510(k) clearance record for ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353, a class I device, cleared for Boehringer Mannheim Corp. on under FDA product code JGJ (Photometric Method, Magnesium). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K983416.

Clearance record

Decision date
Received
(22 days to decision)
Product code
JGJ Photometric Method, Magnesium
Regulation
21 CFR 862.1495
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Boehringer Mannheim Corp. 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code JGJ

Trailing 12 months

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

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