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510(k) K050682

LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) by Bio-Rad Laboratories, Inc. — Product Code DIF

K050682 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)". The FDA issued a decision of Substantially Equivalent on April 29, 2005. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Bio-Rad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2005
Date Received
March 16, 2005
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

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  • K170509 — BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC I (May 19, 2017)
  • K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator (May 11, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K161687 — D-10 Hemoglobin A1c Program (October 14, 2016)
  • K152679 — Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, (May 10, 2016)
  • DEN150058 — Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 (March 28, 2016)

Other clearances for product code DIF

  • K153474 — Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, (February 23, 2016)
  • K132688 — SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/N (December 16, 2013)
  • K132174 — MULTICHEM WBT (September 20, 2013)
  • K121122 — DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL (July 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 (March 27, 2012)
  • K103656 — THERMO SCIENTIFIC MAS R DOA TOTAL (March 24, 2011)
  • K093577 — LIQUICHEK OPIATE CONTROL (March 12, 2010)
  • K080085 — MAS TOX CONTROL (April 30, 2008)
  • K080183 — CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMI (March 25, 2008)

FDA data resources