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510(k) K880483

V-TREND STREP A TEST by Texas Immunology, Inc. — Product Code GTZ

K880483 is an FDA 510(k) premarket notification submitted by Texas Immunology, Inc. for the device "V-TREND STREP A TEST". The FDA issued a decision of Substantially Equivalent on Apr 12, 1988. The device falls under product code GTZ (Antisera, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Texas Immunology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 12, 1988
Date Received
Feb 5, 1988
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 Texas Immunology, Inc.

  • K991465 — DRUG STOP (Dec 10, 1999)
  • K980153 — DRUG CHECK (Mar 27, 1998)
  • K973208 — FIRST SIGN (Oct 20, 1997)
  • K972094 — TARGET CARDIAC TROPONIN I TEST (Jul 23, 1997)
  • K963680 — TARGET MYOGLOBIN TEST (Feb 6, 1997)
  • K912246 — TARGET MICROALBUMINURIA TEST (Jul 19, 1991)
  • K910073 — TARGET ASO TEST (May 21, 1991)
  • K904105 — V-TREND TARGET RF TEST (Oct 15, 1990)
  • K892231 — V-TREND TARGET CRP TEST (Apr 21, 1989)
  • K890423 — V-TREND TARGET CRP TEST (Feb 17, 1989)

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