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510(k) K962817

DRUG CALIBRATOR II by Dade Intl., Inc. — Product Code DKB

K962817 is an FDA 510(k) premarket notification submitted by Dade Intl., Inc. for the device "DRUG CALIBRATOR II". The FDA issued a decision of Substantially Equivalent on September 16, 1996. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Dade Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1996
Date Received
July 19, 1996
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 Dade Intl., Inc.

  • K974343 — DADE INNOVIN (July 22, 1998)
  • K970505 — DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/ (November 17, 1997)
  • K973974 — DADE TRU-LIQUID CARDIAC CONTROL (November 6, 1997)
  • K973668 — CARDIAC TROPONIN-I (TROP) CALIBRATOR (October 20, 1997)
  • K972524 — DRIED GRAM-POSITIVE MIC/COMBO PANELS (September 8, 1997)
  • K972782 — DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (August 15, 1997)
  • K972287 — DADE TRU-LIQUID BILIRUBIN CONTROL (July 7, 1997)
  • K964660 — PARAMAX CHOLESTEROL REAGENT (June 4, 1997)
  • K970676 — DRIED GRAM-NEGATIVE MIC/COMBO PANELS (May 2, 1997)
  • K964715 — PARAMAX SALICYLATE REAGENT (April 25, 1997)

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