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
K905396Substantially Equivalent

Hemastix Reagent Strips

Kulzer GmbH, Mishawaka IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905396 is the FDA 510(k) clearance record for HEMASTIX REAGENT STRIPS, a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code JIO (Blood, Occult, Colorimetric, In Urine). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K905396.

Clearance record

Decision date
Received
(73 days to decision)
Product code
JIO Blood, Occult, Colorimetric, In Urine
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Heraeus Kulzer, Inc. 430 S. Beiger St., Mishawaka IN
Third party review
No

Clearances, product code JIO

Trailing 12 months

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

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