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510(k) K923673

PRECISE STREP A by Becton Dickinson Advanced Diagnostics — Product Code GTZ

K923673 is an FDA 510(k) premarket notification submitted by Becton Dickinson Advanced Diagnostics for the device "PRECISE STREP A". The FDA issued a decision of Substantially Equivalent on September 28, 1992. The device falls under product code GTZ (Antisera, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Becton Dickinson Advanced Diagnostics has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1992
Date Received
July 22, 1992
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 Becton Dickinson Advanced Diagnostics

  • K935667 — QTEST(R) STREP (April 21, 1994)
  • K931294 — IQ TUPTAKE ASSAY (July 22, 1993)
  • K931295 — IQ TT4 ASSAY (July 20, 1993)
  • K926356 — PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG (March 18, 1993)
  • K925132 — BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE (December 28, 1992)
  • K923060 — IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY (September 15, 1992)
  • K914958 — RIATRAC PLUS (March 18, 1992)
  • K915197 — PRECISE TM HCG (December 17, 1991)
  • K915200 — PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA (December 16, 1991)

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