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510(k) K874625

EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY by Syva Co. — Product Code DLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1987
Date Received
November 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
Review Panel
TX
Submission Type

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  • K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (February 1, 2000)
  • K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (January 27, 2000)
  • K993983 — SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL (January 27, 2000)
  • K993986 — SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL (January 27, 2000)

Other clearances for product code DLZ

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  • K123271 — ABBOTT PHENOBARBITAL ASSAY (April 26, 2013)
  • K081231 — ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODE (September 26, 2008)
  • K071644 — ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 (September 12, 2007)
  • K011303 — RANDOX PHENOBARBITAL (July 2, 2001)
  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
  • K000012 — IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 (March 3, 2000)
  • K993031 — ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (January 27, 2000)
  • K984288 — VITROS CHEMISTRY PRODUCTS PHBR SLIDES (January 26, 1999)
  • K946210 — PHENOBARBITAL ENZYME IMMUNOASSAY (February 10, 1995)