510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951361Substantially Equivalent

Dca 2000 System for Hemoglobin A1c

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

K951361 is the FDA 510(k) clearance record for DCA 2000 SYSTEM FOR HEMOGLOBIN A1C, a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code LCP (Assay, Glycosylated Hemoglobin). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show one recall naming K951361.

Clearance record

Decision date
Received
(39 days to decision)
Product code
LCP Assay, Glycosylated Hemoglobin
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Heraeus Kulzer, Inc. P.O. Box 2004, Mishawaka IN
510(k) summary
Summary
Third party review
No

Clearances, product code LCP

Trailing 12 months

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

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