SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)— 510(k) K921939

Name: FDA 510(k) clearance K921939
Creator: U.S. Food and Drug Administration
Published: 1992-07-16

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K921939 for SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR), Substantially Equivalent on 1992-07-16. Applicant: Heraeus Kulzer, Inc.. Device class: 1.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code LAS
Device class: Class 1
Regulation: 21 CFR 862.3280
Advisory panel: Clinical Toxicology
Date received: 1992-04-24
Decision date: 1992-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mishawaka, IN, US

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