510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K895249Substantially Equivalent

Systemate(tm) Iron Item Number: 65417

Em Diagnostic Systems, Inc., Gibbstown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895249 is the FDA 510(k) clearance record for SYSTEMATE(TM) IRON ITEM NUMBER: 65417, a class I device, cleared for Em Diagnostic Systems, Inc. on under FDA product code JIY (Photometric Method, Iron (Non-Heme)). FDA records list 288 510(k) clearances for Em Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K895249.

Clearance record

Decision date
Received
(71 days to decision)
Product code
JIY Photometric Method, Iron (Non-Heme)
Regulation
21 CFR 862.1410
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Em Diagnostic Systems, Inc. 480 Democrat Rd., Gibbstown NJ
Third party review
No

Clearances, product code JIY

Trailing 12 months

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

FDA records show no clearances under product code JIY in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JIY, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260