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510(k) K944159

HM-CAP EIA KIT by Schiff & Co. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1995
Date Received
August 26, 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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  • K896684 — KEMBLE LIQUID HANDLING SYSTEM DISPENSER (April 16, 1990)
  • K894617 — OLYMPUS PK-TP SYSTEM REACTIVE CONTROL (October 31, 1989)

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