510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K921939Substantially Equivalent

Seralyzer(r) Therapeutic Drug Assay Control(abnor)

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

K921939 is the FDA 510(k) clearance record for SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR), a class I device, cleared for Heraeus Kulzer, Inc. on under FDA product code LAS (Drug Specific Control Materials). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K921939.

Clearance record

Decision date
Received
(83 days to decision)
Product code
LAS Drug Specific Control Materials
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Heraeus Kulzer, Inc. P.O. Box 2004, Mishawaka IN
510(k) summary
Summary
Third party review
No

Clearances, product code LAS

Trailing 12 months

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

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