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510(k) K992395

URINE DRUG SCREENING CONTROL by Seracare Technology — Product Code DIF

K992395 is an FDA 510(k) premarket notification submitted by Seracare Technology for the device "URINE DRUG SCREENING CONTROL". The FDA issued a decision of Substantially Equivalent on August 26, 1999. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Seracare Technology has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1999
Date Received
July 19, 1999
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 Seracare Technology

  • K993631 — QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 (December 9, 1999)
  • K992939 — QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 (December 9, 1999)
  • K993715 — QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 (November 16, 1999)
  • K992770 — QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3 (November 12, 1999)

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