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510(k) K881369

ADVANCE DIAGNOSTICS DISPOSABLE EYECUP by Advantage Diagnostics Corp. — Product Code LXQ

K881369 is an FDA 510(k) premarket notification submitted by Advantage Diagnostics Corp. for the device "ADVANCE DIAGNOSTICS DISPOSABLE EYECUP". The FDA issued a decision of Substantially Equivalent on May 13, 1988. The device falls under product code LXQ (Cup, Eye), a Class U device. Advantage Diagnostics Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1988
Date Received
April 1, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cup, Eye
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type

Other clearances by Advantage Diagnostics Corp.

  • K023712 — ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST (January 31, 2003)
  • K013778 — PEACE OF MIND HOME DRUG TEST (February 7, 2002)
  • K011962 — ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST (August 9, 2001)
  • K010921 — ADVANTAGE MARIJUANA (THC) HOME DRUG TEST (June 25, 2001)
  • K003708 — ADVANTAGE THC/COCAINE TEST (January 22, 2001)
  • K001567 — ADVANTAGE THC TEST (June 19, 2000)
  • K994227 — ADVANTAGE HCG TEST (URINE/SERUM) (February 3, 2000)
  • K991883 — REDI-TEST OPIATES (September 15, 1999)
  • K903416 — CANNULA, SURGICAL (November 23, 1990)

Other clearances for product code LXQ

  • K151575 — Dynarex Eye Cups (September 1, 2015)
  • K140409 — FLENTS PLASTIC EYE WASH CUP (July 9, 2014)
  • K051414 — EYE CUP, STERILE 1 AND NON STERILE (June 16, 2005)
  • K971134 — VISTA EYESHOWER (November 4, 1997)

FDA data resources