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510(k) K851132

LATEX AGGLUTINATION TEST by New Horizons Diagnostics Co. — Product Code GTZ

K851132 is an FDA 510(k) premarket notification submitted by New Horizons Diagnostics Co. for the device "LATEX AGGLUTINATION TEST". The FDA issued a decision of Substantially Equivalent on Jul 5, 1985. The device falls under product code GTZ (Antisera, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. New Horizons Diagnostics Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 5, 1985
Date Received
Mar 21, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Groups, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

Other clearances by New Horizons Diagnostics Co.

  • K932622 — CHOLERA SMART(TM) (Jun 27, 1995)
  • K925190 — PYLORISCREEN (Mar 23, 1993)
  • K922432 — CHOLERASCREEN (Dec 7, 1992)
  • K874761 — RAPID COLORIMETRIC DIRECT STREP A TEST (Feb 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) (Jun 30, 1986)
  • K821362 — IMPROVED GONO GEN (Aug 4, 1982)
  • K820007 — NEISSERIA GONORRHOEAE TEST (Jan 29, 1982)

Other clearances for product code GTZ

  • K012521 — BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST (Nov 30, 2001)
  • K011709 — UNI-GOLD STREP A TEST KIT (Nov 8, 2001)
  • K010523 — MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (Mar 15, 2001)
  • K991726 — BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST (Aug 27, 1999)
  • K971522 — ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II (Mar 3, 1998)
  • K962060 — STREP A OIA MAX (Jul 23, 1997)
  • K962296 — STREPTOLEX-STAT (Dec 16, 1996)
  • K961423 — OSOM STREP A TEST (Oct 11, 1996)
  • K962146 — EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT (Oct 7, 1996)
  • K955108 — CARDS Q.S. STREP A (Apr 15, 1996)

FDA data resources