GEN-PROBE PAL LUMINOMETER— 510(k) K903911

Substantially Equivalent

Gen-Probe, Inc.

FDA 510(k) clearance K903911 for GEN-PROBE PAL LUMINOMETER, Substantially Equivalent on 1990-10-04. 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: 1990-08-24
Decision date: 1990-10-04
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.