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510(k) K111363

PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL by Medica Corp. — Product Code JXN

K111363 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL". The FDA issued a decision of Substantially Equivalent on December 6, 2011. The device falls under product code JXN (Enzyme Immunoassay, Propoxyphene), a Class II device regulated under 21 CFR 862.3700. Medica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2011
Date Received
May 16, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Propoxyphene
Device Class
Class II
Regulation Number
862.3700
Review Panel
TX
Submission Type

Other clearances by Medica Corp.

  • K123802 — EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT (March 1, 2013)
  • K120497 — EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL (May 14, 2012)
  • K111005 — ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL (November 15, 2011)
  • K112788 — EASTLYTE NA/K/CA/PH (October 20, 2011)
  • K101089 — EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR (July 13, 2011)
  • K101090 — EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS (May 20, 2011)
  • K110675 — EASYRA UREA NITROGEN AND CREATININE REAGENTS (April 21, 2011)
  • K101088 — EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT (April 4, 2011)
  • K100829 — EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBO (January 14, 2011)
  • K092116 — EASYCELL CELL LOCATOR (May 12, 2010)

Other clearances for product code JXN

  • K152495 — Wondfo Propoxyphene Urine Test (November 23, 2015)
  • K122752 — FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX D (January 30, 2013)
  • K043303 — ONLINE DAT PROPOXYPHENE PLUS (March 11, 2005)
  • K040445 — ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DE (May 19, 2004)
  • K030835 — 'RAPID ONE' - PROPOXYPHENE TEST (May 22, 2003)
  • K023795 — PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST (January 21, 2003)
  • K022915 — INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST (November 29, 2002)
  • K020787 — VERDICT-II PROPOXYPHENE (May 2, 2002)
  • K013100 — PROPOXYPHENE (March 20, 2002)
  • K011163 — MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 (May 10, 2001)

FDA data resources