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510(k) K852841

RAPID DIRECT STREP A LATEX AGGLUTINATION TEST by Smithkline Diagnostics, Inc. — Product Code GTZ

K852841 is an FDA 510(k) premarket notification submitted by Smithkline Diagnostics, Inc. for the device "RAPID DIRECT STREP A LATEX AGGLUTINATION TEST". The FDA issued a decision of Substantially Equivalent on July 24, 1985. The device falls under product code GTZ (Antisera, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Smithkline Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1985
Date Received
July 5, 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 Smithkline Diagnostics, Inc.

  • K961062 — FLEXSURE OBT (November 6, 1996)
  • K960183 — FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS F (June 7, 1996)
  • K934863 — FLEXSURE HP (May 18, 1994)
  • K880499 — HEMOCCULT SENSITIVE TEST (May 23, 1988)
  • K875131 — (SKD) CHOLESTEROL TEST KIT (March 1, 1988)
  • K862849 — HEMOCCULT WIPE TEST (December 9, 1986)
  • K854723 — SKD ELECTROCHEMICAL SYSTEM (ECS) (March 5, 1986)
  • K821884 — GASTROCCULT TM (October 8, 1982)
  • K821674 — SPINCHEM ACID PHOSPHATASE REAGENT (June 22, 1982)
  • K821184 — SPIN CHEM REAGENTS & STANDARDS (May 24, 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