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510(k) K813240

EMIT-AAD THEOPHYLLINE ASSAY by Syva Co. — Product Code LER

K813240 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "EMIT-AAD THEOPHYLLINE ASSAY". The FDA issued a decision of Substantially Equivalent on December 3, 1981. The device falls under product code LER (Fluorescent Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Syva Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1981
Date Received
November 17, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Immunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
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 LER

  • K942192 — THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS (July 13, 1994)
  • K905521 — CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION (December 26, 1990)
  • K882570 — TURBOX THEOPHYLLINE ASSAY (November 10, 1988)
  • K864409 — IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS (December 22, 1986)
  • K863475 — THEOFAST(TM) TEST PACKAGE (November 5, 1986)
  • K842585 — THEOPHYLLINE KIT FLUORESCENCE POLARIZA- (September 26, 1984)
  • K840758 — IMMPULSE THEOPHYLLINE ASSAY REAGENTS (April 4, 1984)
  • K833070 — TDX THEOPHYLLINE (November 14, 1983)
  • K831514 — AMWA TDA THEOPHYLLINE TEST (June 30, 1983)
  • K823576 — COBAS STANDARD FOR TOTAL PROTEIN (January 7, 1983)

FDA data resources