CHOLERA SMART(TM)— 510(k) K932622

Substantially Equivalent

New Horizons Diagnostics Co.

FDA 510(k) clearance K932622 for CHOLERA SMART(TM), Substantially Equivalent on 1995-06-27. Applicant: New Horizons Diagnostics Co.. Device class: 2.

Clearance details

Applicant: New Horizons Diagnostics Co.
Product code: Code GSQ
Device class: Class 2
Regulation: 21 CFR 866.3930
Advisory panel: Microbiology
Date received: 1993-06-01
Decision date: 1995-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GSQ

K954995 — QUIX RAPID CHOLERA STRIP TEST1996-08-15
K922432 — CHOLERASCREEN1992-12-07

More clearances from New Horizons Diagnostics Co.

K925190 — PYLORISCREEN1993-03-23
K874761 — RAPID COLORIMETRIC DIRECT STREP A TEST1988-02-19
K871226 — SYPHILIS SEROLOGICAL REAGENTS1987-05-28
K871105 — THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE1987-05-13
K862195 — RAPID BACTERIURIA SCREEN (RBS)1986-06-30

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