510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915113Substantially Equivalent

Encore

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

K915113 is the FDA 510(k) clearance record for ENCORE, a class I device, cleared for Heraeus Kulzer, Inc. on under FDA product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K915113.

Clearance record

Decision date
Received
(126 days to decision)
Product code
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Regulation
21 CFR 862.2300
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Heraeus Kulzer, Inc. 430 S. Beiger St., Mishawaka IN
510(k) summary
Summary
Third party review
No

Clearances, product code JJQ

Trailing 12 months

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

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