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
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K943780Substantially Equivalent

Negative Control Strips for Urinalysis (Chex-Stix, Clinitek Auto 2000, Clinitex Atlas)

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

K943780 is the FDA 510(k) clearance record for NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS), a class I device, cleared for Heraeus Kulzer, Inc. on under FDA product code JJW (Urinalysis Controls (Assayed And Unassayed)). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show 7 recalls naming K943780.

Clearance record

Decision date
Received
(89 days to decision)
Product code
JJW Urinalysis Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Heraeus Kulzer, Inc. 1127 Myrtle St., Elkhart IN
510(k) summary
Summary
Third party review
No

Clearances, product code JJW

Trailing 12 months

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

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