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510(k) K871226

SYPHILIS SEROLOGICAL REAGENTS by New Horizons Diagnostics Co. — Product Code GMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1987
Date Received
March 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Nontreponemal, All
Device Class
Class II
Regulation Number
866.3820
Review Panel
MI
Submission Type

Other clearances by New Horizons Diagnostics Co.

  • K932622 — CHOLERA SMART(TM) (June 27, 1995)
  • K925190 — PYLORISCREEN (March 23, 1993)
  • K922432 — CHOLERASCREEN (December 7, 1992)
  • K874761 — RAPID COLORIMETRIC DIRECT STREP A TEST (February 19, 1988)
  • 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)

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