DeviceClearance

AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)— 510(k) K113501

Substantially Equivalent

Ameditech, Inc.

FDA 510(k) clearance K113501 for AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP), Substantially Equivalent on 2011-12-05. Applicant: Ameditech, Inc.. Device class: 2.

Clearance details

Applicant
Ameditech, Inc.
Product code
Code DIO
Device class
Class 2
Regulation
21 CFR 862.3250
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 ↗

Recent devices under product code DIO

view all

More clearances from Ameditech, Inc.

view all

Recalls naming K113501

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 K113501.

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