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510(k) K873596

BAKER TDM THEOPHYLLINE ASSAY by Baker Instructions Corp. — Product Code KLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1987
Date Received
September 4, 1987
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

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  • K854173 — UCD URINE SPECIMEN COLLECTOR (November 4, 1985)
  • K850386 — SYSTEM 8000 CELL COUNTER (May 2, 1985)
  • K833116 — SPIRIT CHEMISTRY SYSTEM (November 7, 1983)
  • K832716 — ENCORE CHEMISTRY ANALYZER (October 4, 1983)
  • K830641 — ENCORE CHEMISTRY ANALYZER (April 5, 1983)
  • K821956 — HAEM-C PLUS BLOOD REFERENCE CONTROLS (July 30, 1982)
  • K811694 — CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT (July 1, 1981)

Other clearances for product code KLS

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  • 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)