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510(k) K945558

PREMIER(TM) H. PYLORY by Meridian Diagnostics, Inc. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1995
Date Received
November 14, 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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  • K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA (December 17, 1998)
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  • K980076 — PREMIER PLATINUM HPSA (May 12, 1998)
  • K980077 — PARA-PAK SPINCON (April 2, 1998)
  • K971585 — IMMUNOCARD STAT! ROTAVIRUS (August 20, 1997)

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  • K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (July 22, 2016)
  • K153661 — ImmunoCard STAT! HpSA (March 14, 2016)