VZV TEST— 510(k) K875358

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K875358 for VZV TEST, Substantially Equivalent on 1988-03-31. Applicant: Gull Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code GQX
Device class: Class 2
Regulation: 21 CFR 866.3900
Advisory panel: Microbiology
Date received: 1987-12-31
Decision date: 1988-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GQX

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K853540 — FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY1986-02-04

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