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510(k) K935047

AUTO DELFIA by Wallac OY — Product Code KHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1994
Date Received
October 21, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer, For Clinical Use
Device Class
Class I
Regulation Number
862.2560
Review Panel
CH
Submission Type

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  • K042424 — DELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)

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  • K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (July 21, 1992)
  • K920888 — MICROLITE MICROTITER PLATE LUMINOMETER ML2200 (March 19, 1992)