MODIFIED PARACON(TM) CONCENTRATION KIT— 510(k) K881649

Name: FDA 510(k) clearance K881649
Creator: U.S. Food and Drug Administration
Published: 1988-04-21

Substantially Equivalent

Para Scientific Co.

FDA 510(k) clearance K881649 for MODIFIED PARACON(TM) CONCENTRATION KIT, Substantially Equivalent on 1988-04-21. Applicant: Para Scientific Co.. Device class: 1.

Clearance details

Applicant: Para Scientific Co.
Product code: Code LKS
Device class: Class 1
Regulation: 21 CFR 866.2900
Advisory panel: Microbiology
Date received: 1988-04-15
Decision date: 1988-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

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K853715 — PARA CON TM1985-10-02

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