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510(k) K972495

ACCUMETER THEOPHYLLINE TEST by Chemtrak, Inc. — Product Code KLS

K972495 is an FDA 510(k) premarket notification submitted by Chemtrak, Inc. for the device "ACCUMETER THEOPHYLLINE TEST". The FDA issued a decision of Substantially Equivalent on October 10, 1997. The device falls under product code KLS (Enzyme Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Chemtrak, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1997
Date Received
July 3, 1997
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 Chemtrak, Inc.

  • K965099 — ACCUMETER H. PYLORI TEST (February 20, 1997)
  • K960478 — ACCUMETER H. PYLORI TEST (June 27, 1996)
  • K943279 — ACCUMETER HDL CHOLESTEROL TEST (May 1, 1995)
  • K943599 — CHEM TRAK ACCUMETER (March 21, 1995)
  • K914432 — ACCUMETER(R) CHOLESTEROL SELF-TEST (March 2, 1993)
  • K905405 — CHEMTRAK ACCUMETER CHOLESTEROL TEST (March 19, 1991)

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)
  • K961462 — CEDIA THEOPHYLLINE ASSAY (June 27, 1996)
  • K954569 — IMMULITE THEOPHYLLINE (November 13, 1995)

FDA data resources