GONI-KIT— 510(k) K852582

Substantially Equivalent

Culture Kits, Inc.

FDA 510(k) clearance K852582 for GONI-KIT, Substantially Equivalent on 1985-07-12. Applicant: Culture Kits, Inc.. Device class: 1.

Clearance details

Applicant: Culture Kits, Inc.
Product code: Code JSX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1985-06-18
Decision date: 1985-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwich, NY, US

Download summary PDF View on FDA.gov ↗

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 Culture Kits, Inc.

K911846 — URI-THREE(TM), MODIFICATION1991-10-04
K854672 — CANDI-KIT TM1986-07-11
K853488 — STAPH KIT1985-08-28
K851225 — URINE DUO1985-08-13
K852480 — DERM-KIT1985-07-09

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