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510(k) K934062

BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS by Biotrack, Inc. — Product Code DIF

K934062 is an FDA 510(k) premarket notification submitted by Biotrack, Inc. for the device "BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS". The FDA issued a decision of Substantially Equivalent on December 29, 1993. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Biotrack, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1993
Date Received
August 19, 1993
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 Biotrack, Inc.

  • K934061 — BIOTRACK VALPROIC ACID TEST CARTRIDGE (December 29, 1993)
  • K920525 — BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL (August 5, 1992)
  • K915756 — BIOTRACK CARBAMAZEPINE TEST CARTRIDGE (July 23, 1992)
  • K915755 — BIOTRACK PHENYTOIN TEST CARTRIDGE (July 23, 1992)
  • K903924 — BIOTRACK THEOPHYLLINE QUALITY CONTROLS (September 17, 1990)
  • K900373 — BIOTRACK THEOPHYLLINE TEST CARTRIDGE (May 30, 1990)
  • K900372 — BIOTRACK IMMUNOCHEMISTRY MONITOR (February 23, 1990)
  • K895101 — BIOTRACK HEMOGLOBIN TEST CARTRIDGE (October 10, 1989)
  • K895102 — BIOTRACK PDS MONITOR (October 10, 1989)
  • K895128 — BIOTRACK ALT TEST CARTRIDGE (October 6, 1989)

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