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510(k) K881369

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

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

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  • 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

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  • 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)