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510(k) K882570

TURBOX THEOPHYLLINE ASSAY by Unipath , Ltd. — Product Code LER

K882570 is an FDA 510(k) premarket notification submitted by Unipath , Ltd. for the device "TURBOX THEOPHYLLINE ASSAY". The FDA issued a decision of Substantially Equivalent on November 10, 1988. The device falls under product code LER (Fluorescent Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Unipath , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1988
Date Received
June 22, 1988
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 Unipath , Ltd.

  • K061769 — E.P.T. CERTAINTY 1-STEP PREGNANCY TEST (July 3, 2006)
  • K060128 — CLEARBLUE EASY DIGITAL PREGNANCY TEST (May 25, 2006)
  • K051638 — INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC (December 6, 2005)
  • K050930 — E.P.T. CERTAINTY PREGNANCY TEST (May 12, 2005)
  • K042280 — FACT PLUS ONE-STEP PREGNANCY TEST KIT (September 10, 2004)
  • K041404 — CLEARBLUE EASY EASY READ PREGNANCY TEST (June 8, 2004)
  • K040329 — MODIFICATION TO E.P.T. PREGNANCY TEST (March 8, 2004)
  • K040341 — CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST (March 8, 2004)
  • K033658 — E.P.T. PREGNANCY TEST (January 16, 2004)
  • K032939 — EPT CERTAINTY PREGNANCY TEST (October 20, 2003)

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)
  • 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