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510(k) K911056

DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD by E.I. Dupont DE Nemours & Co., Inc. — Product Code DIP

K911056 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD". The FDA issued a decision of Substantially Equivalent on April 3, 1991. The device falls under product code DIP (Enzyme Immunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1991
Date Received
March 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

Other clearances by E.I. Dupont DE Nemours & Co., Inc.

  • K951851 — ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY (July 24, 1996)
  • K953725 — CRONEX RADIATION THERAPY VERIFICATION CASSETTE (September 6, 1995)
  • K953724 — CRONEX RADIATION THERAPY CASSETTE (September 6, 1995)
  • K951441 — DUPONT ACA DIGOXIN (DGN A) METHOD (June 1, 1995)
  • K950137 — URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE (April 13, 1995)
  • K950181 — URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE (April 5, 1995)
  • K950136 — URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE (April 5, 1995)
  • K950135 — URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE (March 30, 1995)
  • K950427 — URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE (March 21, 1995)
  • K950134 — URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE (March 21, 1995)

Other clearances for product code DIP

  • K080696 — ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1 (September 11, 2008)
  • K063145 — PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS (October 17, 2007)
  • K030428 — ROCHE ONLINE TDM PHENYTOIN (April 28, 2003)
  • K011393 — RANDOX PHENYTOIN (December 4, 2001)
  • K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (May 17, 2001)
  • K000006 — IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2 (February 28, 2000)
  • K993026 — ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS (January 27, 2000)
  • K973414 — ACE PHENYTOIN REAGENT, AED CALIBRATORS (November 4, 1997)
  • K963840 — CEDIA PHENYTOIN II ASSAY (November 20, 1996)
  • K943980 — IL TEST PHENYTION CALIBRATORS (May 1, 1995)

FDA data resources