NIZYME TEST KIT— 510(k) K923566

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K923566 for NIZYME TEST KIT, Substantially Equivalent on 1992-11-02. Applicant: Remel Co.. Device class: 1.

Clearance details

Applicant: Remel Co.
Product code: Code JSX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1992-07-17
Decision date: 1992-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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