MODIFIED IDS RAPID NH SYSTEM— 510(k) K881501

Name: FDA 510(k) clearance K881501
Creator: U.S. Food and Drug Administration
Published: 1988-05-18

Substantially Equivalent

Innovative Diagnostic Systems, Inc.

FDA 510(k) clearance K881501 for MODIFIED IDS RAPID NH SYSTEM, Substantially Equivalent on 1988-05-18. Applicant: Innovative Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Innovative Diagnostic Systems, Inc.
Product code: Code JSX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1988-04-11
Decision date: 1988-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSX

view all

K960759 — GONOPOX TEST KIT1996-09-18
K923566 — NIZYME TEST KIT1992-11-02
K913456 — VISI-NEISSERIA1991-10-11
K880511 — XACT NEISSERIA1988-08-25
K870117 — NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST1987-03-20

More clearances from Innovative Diagnostic Systems, Inc.

view all

K962966 — IDS RAPID CB PLUS SYSTEM1996-10-08
K943621 — RAPID YEAST PLUS SYSTEM1995-01-27
K900517 — RAPID NF SYSTEM1990-03-13
K882960 — IDS RAPID ANA SYSTEM1988-08-12
K852871 — IDS RAPID SS/U SYSTEM1985-07-23

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