DIGENE DML 2000 MICROPLATE LUMINOMETER— 510(k) K980120

Name: FDA 510(k) clearance K980120
Creator: U.S. Food and Drug Administration
Published: 1998-02-06

Substantially Equivalent

Digene Corp.

FDA 510(k) clearance K980120 for DIGENE DML 2000 MICROPLATE LUMINOMETER, Substantially Equivalent on 1998-02-06. Applicant: Digene Corp.. Device class: 1.

Clearance details

Applicant: Digene Corp.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1998-01-13
Decision date: 1998-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beltsville, MD, US

Download summary PDF View on FDA.gov ↗

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