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510(k) K891761

GDS ENZYMATIC THEOPHYLLINE REAGENT by Gds Diagnostics — Product Code LCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1989
Date Received
March 24, 1989
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

Other clearances by Gds Diagnostics

  • K931257 — ACETASITE (July 8, 1993)
  • K910881 — CONTROL AND LINEARITY (September 13, 1991)
  • K910108 — GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED (March 4, 1991)

Other clearances for product code LCY

  • K780441 — THEOPHYLLINE ASSAY TO THE CENTRIFICHEM (April 12, 1978)
  • K780442 — THEOPHYLLINE ASSAY TO THE GEMSAEC (April 12, 1978)