GONOPOX TEST KIT— 510(k) K960759

Substantially Equivalent

Medtex Laboratories, Inc.

FDA 510(k) clearance K960759 for GONOPOX TEST KIT, Substantially Equivalent on 1996-09-18. Applicant: Medtex Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Medtex Laboratories, Inc.
Product code: Code JSX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1996-02-26
Decision date: 1996-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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K881501 — MODIFIED IDS RAPID NH SYSTEM1988-05-18
K870117 — NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST1987-03-20

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