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510(k) K811674

DRUG STANDARDS by Supelco, Inc. — Product Code DKB

K811674 is an FDA 510(k) premarket notification submitted by Supelco, Inc. for the device "DRUG STANDARDS". The FDA issued a decision of Substantially Equivalent on July 15, 1981. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Supelco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1981
Date Received
June 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

Other clearances by Supelco, Inc.

  • K894141 — LIQUID CHROMATOGRAPHY COLUMNS (August 21, 1989)
  • K884403 — LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE (December 22, 1988)
  • K883615 — LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 (December 16, 1988)
  • K881868 — LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD (August 29, 1988)
  • K881361 — SOLID PHASE EXTRACTION TUBES (August 8, 1988)
  • K880724 — LIQUID CHROMATO. COLUMNS (May 27, 1988)
  • K874824 — CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY (January 21, 1988)
  • K871174 — 4-9295 BARBITURATES TEST MIX (June 11, 1987)
  • K862542 — CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY (August 4, 1986)
  • K862541 — LIQUID CHROMATOGRAPHY COLUMNS (July 29, 1986)

Other clearances for product code DKB

  • K141928 — COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR (November 25, 2014)
  • K133710 — LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS (February 21, 2014)
  • K120936 — ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT (December 13, 2012)
  • K092266 — RANDOX METHAMPHETAMINE ASSAY (May 9, 2011)
  • K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (April 8, 2011)
  • K090939 — ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLIN (June 18, 2009)
  • K090900 — ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 (June 1, 2009)
  • K062162 — DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) (September 14, 2006)
  • K062121 — DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) (August 25, 2006)
  • K060645 — PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRAT (May 30, 2006)

FDA data resources