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510(k) K780441

THEOPHYLLINE ASSAY TO THE CENTRIFICHEM by Syva Co. — Product Code LCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1978
Date Received
March 20, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
U.V. Spectrometry, Theophylline
Device Class
Class II
Regulation Number
862.3880
Review Panel
TX
Submission Type

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  • K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (June 6, 2001)
  • K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (May 17, 2001)
  • K993981 — SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL (February 1, 2000)
  • 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)
  • K993986 — SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL (January 27, 2000)
  • K993985 — SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL (January 27, 2000)

Other clearances for product code LCY

  • K891761 — GDS ENZYMATIC THEOPHYLLINE REAGENT (May 16, 1989)
  • K780442 — THEOPHYLLINE ASSAY TO THE GEMSAEC (April 12, 1978)