510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K934898Substantially Equivalent

Glucometer Qa Blood Glucose Meter Modification

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

K934898 is the FDA 510(k) clearance record for GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION, a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code CGA (Glucose Oxidase, Glucose). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K934898.

Clearance record

Decision date
Received
(55 days to decision)
Product code
CGA Glucose Oxidase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Heraeus Kulzer, Inc. P.O. Box 2004, Mishawaka IN
510(k) summary
Summary
Third party review
No

Clearances, product code CGA

Trailing 12 months
1 clearance under product code CGA in the twelve months to November 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260