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510(k) K890041

V-TREND TARGET IM TEST by Texas Immunology, Inc. — Product Code KTN

K890041 is an FDA 510(k) premarket notification submitted by Texas Immunology, Inc. for the device "V-TREND TARGET IM TEST". The FDA issued a decision of Substantially Equivalent on January 23, 1989. The device falls under product code KTN (System, Test, Infectious Mononucleosis), a Class II device regulated under 21 CFR 866.5640. Texas Immunology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1989
Date Received
January 5, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Infectious Mononucleosis
Device Class
Class II
Regulation Number
866.5640
Review Panel
MI
Submission Type

Other clearances by Texas Immunology, Inc.

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

Other clearances for product code KTN

  • K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health M (June 22, 2018)
  • K042272 — ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) (February 28, 2005)
  • K030215 — BIORAPID MONONUCLEOSIS (February 24, 2003)
  • K012901 — COLOR-MONOGEN (September 27, 2001)
  • K982634 — DRYSPOT INFECTIOUS MONONUCLEOSIS KIT (January 28, 1999)
  • K981946 — CLEARVIEW IM (December 10, 1998)
  • K972457 — MONOCOL/LEX-IM TEST (December 1, 1997)
  • K972231 — OSOM MONO TEST 143 (August 26, 1997)
  • K963425 — GENZYME DIAGNOSTICS CONTRAST MONO (February 25, 1997)
  • K961024 — BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB (February 4, 1997)

FDA data resources