DeviceClearance

AMEDITECH IMMUTEST MILTI-DRUG SCREEN— 510(k) K113046

Substantially Equivalent

Ameditech, Inc.

FDA 510(k) clearance K113046 for AMEDITECH IMMUTEST MILTI-DRUG SCREEN, Substantially Equivalent on 2011-11-10. Applicant: Ameditech, Inc.. Device class: 2.

Clearance details

Applicant
Ameditech, Inc.
Product code
Code DKZ
Device class
Class 2
Regulation
21 CFR 862.3100
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

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Recalls naming K113046

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113046.

Data sourced from openFDA. This site is unofficial and independent of the FDA.