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510(k) K905521

CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION by Microgenics Corp. — Product Code LER

K905521 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION". The FDA issued a decision of Substantially Equivalent on December 26, 1990. The device falls under product code LER (Fluorescent Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Microgenics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1990
Date Received
December 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Microgenics Corp.

  • K122766 — THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY (August 20, 2013)
  • K123343 — THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS (July 11, 2013)
  • K123271 — ABBOTT PHENOBARBITAL ASSAY (April 26, 2013)
  • K110616 — THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO (June 29, 2011)
  • K101746 — THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY (April 8, 2011)
  • K101754 — THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY (April 8, 2011)
  • K101753 — THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY (April 8, 2011)
  • K101742 — THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY (April 8, 2011)
  • K101744 — THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY (April 8, 2011)
  • K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (April 8, 2011)

Other clearances for product code LER

  • K942192 — THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS (July 13, 1994)
  • K882570 — TURBOX THEOPHYLLINE ASSAY (November 10, 1988)
  • K864409 — IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS (December 22, 1986)
  • K863475 — THEOFAST(TM) TEST PACKAGE (November 5, 1986)
  • K842585 — THEOPHYLLINE KIT FLUORESCENCE POLARIZA- (September 26, 1984)
  • K840758 — IMMPULSE THEOPHYLLINE ASSAY REAGENTS (April 4, 1984)
  • K833070 — TDX THEOPHYLLINE (November 14, 1983)
  • K831514 — AMWA TDA THEOPHYLLINE TEST (June 30, 1983)
  • K823576 — COBAS STANDARD FOR TOTAL PROTEIN (January 7, 1983)
  • K820397 — AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM (March 2, 1982)

FDA data resources