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510(k) K993026

ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS by Syva Co. — Product Code DIP

K993026 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS". The FDA issued a decision of Substantially Equivalent on January 27, 2000. The device falls under product code DIP (Enzyme Immunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2000
Date Received
September 9, 1999
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 Syva Co.

  • K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRA (August 13, 2001)
  • K012257 — EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 (August 3, 2001)
  • K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (July 2, 2001)
  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
  • K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (May 17, 2001)
  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (February 1, 2000)
  • K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (January 27, 2000)
  • K993988 — SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL (January 27, 2000)
  • K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (January 27, 2000)

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)
  • 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)
  • K945725 — PHENYTION EIA TEST (February 3, 1995)

FDA data resources