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510(k) K944903

HP-FAST by Gi Supply — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1995
Date Received
October 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

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  • K970187 — RUNYON LARGE VOLUME PARACENTESIS KIT (February 14, 1997)
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  • K915816 — BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY (March 27, 1992)

Other clearances for product code LYR

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  • K183573 — Vstrip H. pylori Antigen Rapid Test (March 14, 2019)
  • K182559 — PREMIER Platinum HpSA PLUS (November 5, 2018)
  • K181464 — LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (August 31, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (July 22, 2016)
  • K153661 — ImmunoCard STAT! HpSA (March 14, 2016)