510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K930685Substantially Equivalent

Technicon H* 3Tm Rtc System (in-Vitro Diag.syst.)

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

K930685 is the FDA 510(k) clearance record for TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.), a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code GKL (Counter, Cell, Automated (Particle Counter)). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K930685.

Clearance record

Decision date
Received
(132 days to decision)
Product code
GKL Counter, Cell, Automated (Particle Counter)
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Heraeus Kulzer, Inc. 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary
Third party review
No

Clearances, product code GKL

Trailing 12 months

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

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