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510(k) K944372

STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA by Solarcare, Inc. — Product Code JXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1995
Date Received
September 7, 1994
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 Solarcare, Inc.

  • K934775 — STC COCAINE METABOLITE EIA (July 14, 1995)
  • K941496 — SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY (October 27, 1994)
  • K941497 — SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY (May 24, 1994)
  • K934376 — STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA (December 7, 1993)
  • K933327 — HISTOFREEZER (October 29, 1993)

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)