GONOCHEK-II— 510(k) K833180

Substantially Equivalent

E-Y Laboratories, Inc.

FDA 510(k) clearance K833180 for GONOCHEK-II, Substantially Equivalent on 1983-11-14. Applicant: E-Y Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: E-Y Laboratories, Inc.
Product code: Code JSX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1983-09-19
Decision date: 1983-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code JSX

K960759 — GONOPOX TEST KIT1996-09-18
K923566 — NIZYME TEST KIT1992-11-02
K913456 — VISI-NEISSERIA1991-10-11
K880511 — XACT NEISSERIA1988-08-25
K881501 — MODIFIED IDS RAPID NH SYSTEM1988-05-18

More clearances from E-Y Laboratories, Inc.

K934130 — SWABZYME OXIDASE1994-09-14
K934125 — GONOCHEK-II, MODIFICATION1994-09-09
K940161 — B-LACTAMASE REAGENT TUBES1994-09-09
K940162 — GONOCHEK II REAGENT TUBES1994-09-09
K934129 — STREP-A-CHEK1994-08-26

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