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510(k) K842827

STREPTEX DIRECT A ZL14 by Wellcome Diagnostics — Product Code GTZ

K842827 is an FDA 510(k) premarket notification submitted by Wellcome Diagnostics for the device "STREPTEX DIRECT A ZL14". The FDA issued a decision of Substantially Equivalent on August 16, 1984. The device falls under product code GTZ (Antisera, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Wellcome Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1984
Date Received
July 20, 1984
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 Wellcome Diagnostics

  • K915203 — D-DIMER WELLCOTEST (HA10) (January 31, 1992)
  • K910797 — STREPTEX ACID EXTRACTION KIT (March 29, 1991)
  • K895461 — WELLCOLEX COLOUR SHIGELLA TEST ZC51 (January 11, 1990)
  • K890146 — WELLCOLEX COLOUR SALMONELLA TEST ZL 50 (February 16, 1989)
  • K875311 — WELLCOZYME HSV WZO2 (August 3, 1988)
  • K861628 — WELLCOZYME ROTAVIRUS WZ01 (January 21, 1987)
  • K864206 — REVEAL COLOUR STREP A ZL16 (January 13, 1987)
  • K861634 — THE WELLCOME ROTAVIRUS LATEX TEST ZL40 (October 29, 1986)
  • K854852 — WELLCOGEN BACTERIAL ANTIGEN KIT (February 4, 1986)
  • K854851 — WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 (February 4, 1986)

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