GONO-CELL— 510(k) K782013

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K782013 for GONO-CELL, Substantially Equivalent on 1979-04-23. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code JSX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1978-12-05
Decision date: 1979-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSX

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K923566 — NIZYME TEST KIT1992-11-02
K913456 — VISI-NEISSERIA1991-10-11
K880511 — XACT NEISSERIA1988-08-25
K881501 — MODIFIED IDS RAPID NH SYSTEM1988-05-18

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