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510(k) K854183

IN VITRO TEST DETERMINATION OF THEOPHYLLINE by Clinical Data, Inc. — Product Code KLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1985
Date Received
October 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
Review Panel
TX
Submission Type

Other clearances by Clinical Data, Inc.

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  • K040631 — VITALAB DIRECT BILIRUBIN REAGENT (March 18, 2004)
  • K040534 — VITALAB AMYLASE REAGENT (March 11, 2004)
  • K034000 — VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (March 10, 2004)
  • K040467 — VITALAB URIC ACID REAGENT (March 8, 2004)
  • K040508 — VITALAB MAGNESIUM REAGENT (March 8, 2004)
  • K031042 — ATAC HEMOGLOBIN A1C REAGENT KIT (November 3, 2003)
  • K031044 — ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (July 15, 2003)

Other clearances for product code KLS

  • K042520 — VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II (November 30, 2004)
  • K042407 — EMIT CAFFEINE ASSAY (October 28, 2004)
  • K020740 — ROCHE ONLINE THEOPHYLLINE (April 16, 2002)
  • K011771 — RANDOX THEOPHYLLINE (January 17, 2002)
  • K013272 — ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY (October 25, 2001)
  • K011166 — MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 (May 10, 2001)
  • K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (January 27, 2000)
  • K973583 — ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS (November 12, 1997)
  • K972495 — ACCUMETER THEOPHYLLINE TEST (October 10, 1997)
  • K961462 — CEDIA THEOPHYLLINE ASSAY (June 27, 1996)