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510(k) K932622

CHOLERA SMART(TM) by New Horizons Diagnostics Co. — Product Code GSQ

K932622 is an FDA 510(k) premarket notification submitted by New Horizons Diagnostics Co. for the device "CHOLERA SMART(TM)". The FDA issued a decision of Substantially Equivalent on June 27, 1995. The device falls under product code GSQ (Antiserum, Vibrio Cholerae, All Varieties), a Class II device regulated under 21 CFR 866.3930. New Horizons Diagnostics Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1995
Date Received
June 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Vibrio Cholerae, All Varieties
Device Class
Class II
Regulation Number
866.3930
Review Panel
MI
Submission Type

Other clearances by New Horizons Diagnostics Co.

  • K925190 — PYLORISCREEN (March 23, 1993)
  • K922432 — CHOLERASCREEN (December 7, 1992)
  • K874761 — RAPID COLORIMETRIC DIRECT STREP A TEST (February 19, 1988)
  • K871226 — SYPHILIS SEROLOGICAL REAGENTS (May 28, 1987)
  • K871105 — THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE (May 13, 1987)
  • K862195 — RAPID BACTERIURIA SCREEN (RBS) (June 30, 1986)
  • K851132 — LATEX AGGLUTINATION TEST (July 5, 1985)
  • K821362 — IMPROVED GONO GEN (August 4, 1982)
  • K820007 — NEISSERIA GONORRHOEAE TEST (January 29, 1982)

Other clearances for product code GSQ

  • K954995 — QUIX RAPID CHOLERA STRIP TEST (August 15, 1996)
  • K922432 — CHOLERASCREEN (December 7, 1992)

FDA data resources