RAPID BACTERIURIA SCREEN (RBS)— 510(k) K862195

Name: FDA 510(k) clearance K862195
Creator: U.S. Food and Drug Administration
Published: 1986-06-30

Substantially Equivalent

New Horizons Diagnostics Co.

FDA 510(k) clearance K862195 for RAPID BACTERIURIA SCREEN (RBS), Substantially Equivalent on 1986-06-30. Applicant: New Horizons Diagnostics Co.. Device class: 1.

Clearance details

Applicant: New Horizons Diagnostics Co.
Product code: Code JXA
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1986-06-09
Decision date: 1986-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXA

view all

K011043 — OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)2001-11-30
K981084 — URISCREEN1998-10-07
K972676 — URINE SCREENING DEVICE1998-02-23
K952246 — TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT1995-06-20
K950257 — MULTIPLE (IZON DBS & URINE COLLECTION KIT)1995-04-14

More clearances from New Horizons Diagnostics Co.

view all

K932622 — CHOLERA SMART(TM)1995-06-27
K925190 — PYLORISCREEN1993-03-23
K922432 — CHOLERASCREEN1992-12-07
K874761 — RAPID COLORIMETRIC DIRECT STREP A TEST1988-02-19
K871226 — SYPHILIS SEROLOGICAL REAGENTS1987-05-28

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