MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT— 510(k) K880665

Name: FDA 510(k) clearance K880665
Creator: U.S. Food and Drug Administration
Published: 1988-03-01

Substantially Equivalent

Allelix Diagnostics, Inc.

FDA 510(k) clearance K880665 for MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT, Substantially Equivalent on 1988-03-01. Applicant: Allelix Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Allelix Diagnostics, Inc.
Product code: Code GTZ
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 1988-02-18
Decision date: 1988-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada L4v 1p1, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code GTZ

view all

K012521 — BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST2001-11-30
K011709 — UNI-GOLD STREP A TEST KIT2001-11-08
K010523 — MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST2001-03-15
K991726 — BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI1999-08-27
K971522 — ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II1998-03-03

More clearances from Allelix Diagnostics, Inc.

view all

K885298 — VISUWELL REAGIN TEST 960 TEST KIT1989-03-15

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