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510(k) K862817

V-TREND QC TDM CONTROL SERUM 1,2,3. by Texas Immunology, Inc. — Product Code DIF

K862817 is an FDA 510(k) premarket notification submitted by Texas Immunology, Inc. for the device "V-TREND QC TDM CONTROL SERUM 1,2,3.". The FDA issued a decision of Substantially Equivalent on Aug 19, 1986. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Texas Immunology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 19, 1986
Date Received
Jul 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Mixture Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
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 DIF

  • K153474 — Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, (Feb 23, 2016)
  • K132688 — SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/N (Dec 16, 2013)
  • K132174 — MULTICHEM WBT (Sep 20, 2013)
  • K121122 — DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL (Jul 3, 2012)
  • K121143 — LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) (May 18, 2012)
  • K120504 — LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOG (Mar 27, 2012)
  • K103656 — THERMO SCIENTIFIC MAS R DOA TOTAL (Mar 24, 2011)
  • K093577 — LIQUICHEK OPIATE CONTROL (Mar 12, 2010)
  • K080085 — MAS TOX CONTROL (Apr 30, 2008)
  • K080183 — CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMI (Mar 25, 2008)

FDA data resources