LYTENING TM 6/R— 510(k) K904726

Substantially Equivalent

Amdev, Inc.

FDA 510(k) clearance K904726 for LYTENING TM 6/R, Substantially Equivalent on 1990-12-18. Applicant: Amdev, Inc.. Device class: 2.

Clearance details

Applicant: Amdev, Inc.
Product code: Code JFP
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 1990-10-17
Decision date: 1990-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Amdev, Inc.

K890524 — APEC GLUCOSE ANALYZER1989-03-15
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K880917 — LYTENING 51988-05-27
K863521 — LYTENING 21986-11-05
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Data sourced from openFDA. This site is unofficial and independent of the FDA.