VENTRESCREEN STREP A TEST— 510(k) K842239

Name: FDA 510(k) clearance K842239
Creator: U.S. Food and Drug Administration
Published: 1984-07-02

Substantially Equivalent

Ventrex Laboratories, Inc.

FDA 510(k) clearance K842239 for VENTRESCREEN STREP A TEST, Substantially Equivalent on 1984-07-02. Applicant: Ventrex Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Ventrex Laboratories, Inc.
Product code: Code GWC
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 1984-06-05
Decision date: 1984-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWC

view all

K884965 — BACTIGEN(R) MENINGITIDIS PANEL1989-02-07
K884966 — BACTIGEN(R) S. PNEUMONIAE1989-02-07
K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE1987-03-25
K862848 — LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-1101986-12-18
K841376 — WELLCOGEN S. PNEUMONIAE1984-05-02

More clearances from Ventrex Laboratories, Inc.

view all

K914554 — SPECIFIC IGE EIA-TURBO ASSAY1992-03-13
K913833 — VENTREX ALLERGEN DISC1992-02-21
K913434 — VENTREX COATED TUBE INTACT PTH1991-10-25
K905612 — VENTREX COATED TUBE IGE RADIOIMMUNOASSAY1991-02-21
K905636 — VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY1991-02-07

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