GEN-PROBE (R) LUMINOMETER - LEADER (TM)— 510(k) K872219

Name: FDA 510(k) clearance K872219
Creator: U.S. Food and Drug Administration
Published: 1987-08-21

Substantially Equivalent

Gen-Probe, Inc.

FDA 510(k) clearance K872219 for GEN-PROBE (R) LUMINOMETER - LEADER (TM), Substantially Equivalent on 1987-08-21. Applicant: Gen-Probe, Inc.. Device class: 1.

Clearance details

Applicant: Gen-Probe, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1987-06-12
Decision date: 1987-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.