IMPROVED GONO GEN— 510(k) K821362

Substantially Equivalent

New Horizons Diagnostics Co.

FDA 510(k) clearance K821362 for IMPROVED GONO GEN, Substantially Equivalent on 1982-08-04. Applicant: New Horizons Diagnostics Co.. Device class: 2.

Clearance details

Applicant: New Horizons Diagnostics Co.
Product code: Code LIC
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1982-05-07
Decision date: 1982-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIC

K921075 — PHADEBACT MONOCLONAL GC TEST, MODIFICATION1992-05-22
K911430 — IDEIA(TM) CHLAMYDIA, MODIFICATION1991-08-07
K880076 — G-MARK1988-07-01
K874078 — MERITEC(TM)-GC1987-12-09
K871105 — THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE1987-05-13

More clearances from New Horizons Diagnostics Co.

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.