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510(k) K842585

THEOPHYLLINE KIT FLUORESCENCE POLARIZA- by Windsor Laboratories, Inc. — Product Code LER

K842585 is an FDA 510(k) premarket notification submitted by Windsor Laboratories, Inc. for the device "THEOPHYLLINE KIT FLUORESCENCE POLARIZA-". The FDA issued a decision of Substantially Equivalent on September 26, 1984. The device falls under product code LER (Fluorescent Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Windsor Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1984
Date Received
July 3, 1984
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 Windsor Laboratories, Inc.

  • K873281 — CARBAMAZEPINE (FPIA) CALIBRATOR KIT (October 28, 1987)
  • K873282 — CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY (September 22, 1987)
  • K871486 — (FPIA) ASSAY BUFFER (May 8, 1987)
  • K870390 — PHENOBARBITAL (FPIA) CALIBRATOR KIT (April 1, 1987)
  • K870389 — DIGOXIN (FPIA) CALIBRATOR KIT (April 1, 1987)
  • K864333 — DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY (January 5, 1987)
  • K863625 — PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT (November 10, 1986)
  • K863244 — AMIKACIN (FPIA) CALIBRATOR KIT (August 29, 1986)
  • K862248 — AMIKACIN KIT (FPIA) (August 4, 1986)
  • K861768 — THEOPHYLLINE (FPIA) CALIBRATOR KIT (June 25, 1986)

Other clearances for product code LER

  • K942192 — THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS (July 13, 1994)
  • K905521 — CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION (December 26, 1990)
  • 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)
  • 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