COLOR VUE TM- MYCOPLASMA PNEUMONIAE— 510(k) K910833

Name: FDA 510(k) clearance K910833
Creator: U.S. Food and Drug Administration
Published: 1991-06-24

Substantially Equivalent

Seradyn, Inc.

FDA 510(k) clearance K910833 for COLOR VUE TM- MYCOPLASMA PNEUMONIAE, Substantially Equivalent on 1991-06-24. Applicant: Seradyn, Inc.. Device class: 1.

Clearance details

Applicant: Seradyn, Inc.
Product code: Code GSA
Device class: Class 1
Regulation: 21 CFR 866.3375
Advisory panel: Microbiology
Date received: 1991-02-27
Decision date: 1991-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.