AMS GRAM-POSITIVE IDENT. CARD— 510(k) K834389

Name: FDA 510(k) clearance K834389
Creator: U.S. Food and Drug Administration
Published: 1984-03-09

Substantially Equivalent

Vitek Systems, Inc.

FDA 510(k) clearance K834389 for AMS GRAM-POSITIVE IDENT. CARD, Substantially Equivalent on 1984-03-09. Applicant: Vitek Systems, Inc.. Device class: 1.

Clearance details

Applicant: Vitek Systems, Inc.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1983-12-14
Decision date: 1984-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTO

view all

K050352 — IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT2005-09-01
K970832 — PYR SWAB1997-04-24
K970834 — GRAM SWAB1997-04-17
K970833 — INDOLE SWAB1997-04-02
K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN1997-02-06

More clearances from Vitek Systems, Inc.

view all

K920661 — VIDAS CMV IGG ASSAY1993-02-12
K921302 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM1992-07-28
K921176 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM1992-04-08
K920952 — VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY1992-04-07
K915884 — VIDAS CHLAMYDIA ASSAY, MODIFICATION1992-03-04

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