Cleared Traditional

ACE(TM) CEDIA(R) PHENYTOIN ASSAY

K944085 · Schiapparelli Biosystems, Inc. · Chemistry
Dec 1994
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K944085 is an FDA 510(k) clearance for the ACE(TM) CEDIA(R) PHENYTOIN ASSAY, a Enzyme Immunoassay, Diphenylhydantoin (Class II — Special Controls, product code DIP), submitted by Schiapparelli Biosystems, Inc. (Columbia, US). The FDA issued a Cleared decision on December 28, 1994, 128 days after receiving the submission on August 22, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3350.

Submission Details

510(k) Number K944085 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 1994
Decision Date December 28, 1994
Days to Decision 128 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DIP — Enzyme Immunoassay, Diphenylhydantoin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3350

Similar Devices — DIP Enzyme Immunoassay, Diphenylhydantoin

All 43
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01
K080696 · Abbott Laboratories · Sep 2008
PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
K063145 · Thermo Electron OY · Oct 2007
ROCHE ONLINE TDM PHENYTOIN
K030428 · Roche Diagnostics Corp. · Apr 2003
RANDOX PHENYTOIN
K011393 · Randox Laboratories, Ltd. · Dec 2001
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
K011347 · Syva Co. · May 2001
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6
K000006 · Diagnostic Products Corp. · Feb 2000