Home / 510(k) Clearances / K853857

510(k) K853857

V-TREND ASO PLUS LATEX TEST by Texas Immunology, Inc. — Product Code GTQ

K853857 is an FDA 510(k) premarket notification submitted by Texas Immunology, Inc. for the device "V-TREND ASO PLUS LATEX TEST". The FDA issued a decision of Substantially Equivalent on Oct 16, 1985. The device falls under product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent), a Class I device regulated under 21 CFR 866.3720. Texas Immunology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 16, 1985
Date Received
Sep 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antistreptolysin - Titer/Streptolysin O Reagent
Device Class
Class I
Regulation Number
866.3720
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 GTQ

  • K052645 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PROD (Dec 14, 2005)
  • K953437 — OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT (Oct 20, 1995)
  • K915742 — TURBIQUANT ASL (Jun 28, 1993)
  • K926236 — BECKMAN ANTI-STREPTOLYSIN O KIT (Jun 15, 1993)
  • K924247 — ACCUTEX ASO LATEX TEST (Dec 7, 1992)
  • K922723 — TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL (Sep 18, 1992)
  • K915053 — BECKMAN ANTISTREPTOLYSIN O, MODIFICATION (Mar 19, 1992)
  • K912150 — BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT (Jul 17, 1991)
  • K904416 — CROATEST (R) RHEUMATOID DIAGNOSTIC (Jun 24, 1991)
  • K910885 — QM300 CALIBRATOR G PACK (Jun 17, 1991)

FDA data resources