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510(k) K952056

IMMUNOASSAY DRUGS OF ABUSE CONTROLS by Medi-Tech, Inc. — Product Code DIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1995
Date Received
May 2, 1995
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 Medi-Tech, Inc.

  • K954457 — MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER (May 15, 1996)
  • K952345 — MEDI-TECH PLATFORM GUIDE CATHETER (August 17, 1995)
  • K945289 — DOA - IMMUNOASSAY CUT-OFF CALIBRATOR (December 13, 1994)
  • K942551 — THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED (October 6, 1994)
  • K943290 — BILIRUBIN PLUS/PEDIATRIC CONTROLS (September 14, 1994)
  • K922990 — HEMODIALYSIS BATH (September 12, 1994)
  • K942552 — THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED (September 9, 1994)
  • K904073 — COAGULATION REFERENCE PLASMA, ABNORMAL (October 22, 1990)
  • K895819 — MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL (November 2, 1989)
  • K873295 — PROSTATIC URETHRO. BALLOON DILATATION CATHETER (July 31, 1989)

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  • 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)