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510(k) K951133

CEDIA DAU PROPOXYPHENE ASSAY by Microgenics Corp. — Product Code JXN

K951133 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "CEDIA DAU PROPOXYPHENE ASSAY". The FDA issued a decision of Substantially Equivalent on May 2, 1995. The device falls under product code JXN (Enzyme Immunoassay, Propoxyphene), a Class II device regulated under 21 CFR 862.3700. Microgenics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1995
Date Received
March 13, 1995
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 Microgenics Corp.

  • K122766 — THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY (August 20, 2013)
  • K123343 — THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS (July 11, 2013)
  • K123271 — ABBOTT PHENOBARBITAL ASSAY (April 26, 2013)
  • K110616 — THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO (June 29, 2011)
  • K101746 — THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY (April 8, 2011)
  • K101754 — THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY (April 8, 2011)
  • K101753 — THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY (April 8, 2011)
  • K101742 — THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY (April 8, 2011)
  • K101744 — THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY (April 8, 2011)
  • K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (April 8, 2011)

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)
  • K111363 — PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL (December 6, 2011)
  • 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)

FDA data resources