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510(k) K862403

EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 by Diagnostic Systems — Product Code DKB

K862403 is an FDA 510(k) premarket notification submitted by Diagnostic Systems for the device "EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95". The FDA issued a decision of Substantially Equivalent on Jul 11, 1986. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Diagnostic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 11, 1986
Date Received
Jun 26, 1986
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 Diagnostic Systems

  • K905146 — OLYMPUS URINE PH (Feb 4, 1991)
  • K893691 — EMDS CREATINE KINASE ITEM NIMBER 65411 (Aug 31, 1989)
  • K893692 — EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 (Aug 21, 1989)
  • K893966 — HDL PRECIPITATING REAGENT (Jul 25, 1989)
  • K884993 — VISUAL BLOOD GLUCOSE TEST SYSTEM (Dec 29, 1988)
  • K881116 — EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 (Jun 20, 1988)
  • K880787 — EASY-TEST LACTIC ACID (LA) (Mar 15, 1988)
  • K854784 — ABSORBANCE (ABS) TEST PAK (Dec 19, 1985)
  • K853699 — EASY ANALYZER & EASY-TEST REAGENT (Sep 25, 1985)
  • K853532 — ALCOHOL CALIBRATORS (Sep 16, 1985)

Other clearances for product code DKB

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

FDA data resources