DELFIA TM HLH KIT— 510(k) K855173

Substantially Equivalent

Lkb Instruments, Inc.

FDA 510(k) clearance K855173 for DELFIA TM HLH KIT, Substantially Equivalent on 1986-02-28. Applicant: Lkb Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Lkb Instruments, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1985-12-26
Decision date: 1986-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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K871599 — DELFIA(TM) HIGE KIT1987-06-12
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