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510(k) K874761

RAPID COLORIMETRIC DIRECT STREP A TEST by New Horizons Diagnostics Co. — Product Code GTZ

K874761 is an FDA 510(k) premarket notification submitted by New Horizons Diagnostics Co. for the device "RAPID COLORIMETRIC DIRECT STREP A TEST". The FDA issued a decision of Substantially Equivalent on February 19, 1988. 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
February 19, 1988
Date Received
November 19, 1987
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) (June 27, 1995)
  • K925190 — PYLORISCREEN (March 23, 1993)
  • K922432 — CHOLERASCREEN (December 7, 1992)
  • 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 GTZ

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

FDA data resources