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510(k) K855227

MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL by Bioclinical Systems, Inc. — Product Code KLS

K855227 is an FDA 510(k) premarket notification submitted by Bioclinical Systems, Inc. for the device "MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL". The FDA issued a decision of Substantially Equivalent on April 11, 1986. The device falls under product code KLS (Enzyme Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Bioclinical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1986
Date Received
December 30, 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 Bioclinical Systems, Inc.

  • K950196 — CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (June 30, 1995)
  • K945911 — CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS (April 4, 1995)
  • K933122 — MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR (February 9, 1994)
  • K933121 — MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR (February 3, 1994)
  • K873086 — ROUND 1 (August 24, 1987)
  • K860334 — VISI-CHECK HLH TEST MONOCLONAL (April 21, 1986)
  • K860333 — MICRO-ELISA HLH TEST KIT MONOCLONAL (April 21, 1986)
  • K854059 — MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO (January 13, 1986)
  • K854379 — MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT (January 7, 1986)
  • K850257 — BCS GLUCOSE COLORIMETRIC TEST (March 5, 1985)

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)

FDA data resources