STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126— 510(k) K122945

Name: FDA 510(k) clearance K122945
Creator: U.S. Food and Drug Administration
Published: 2013-04-30

Substantially Equivalent

Steritec Products Mfg Co, Inc.

FDA 510(k) clearance K122945 for STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126, Substantially Equivalent on 2013-04-30. Applicant: Steritec Products Mfg Co, Inc.. Device class: 2.

Clearance details

Applicant: Steritec Products Mfg Co, Inc.
Product code: Code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2012-09-24
Decision date: 2013-04-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Engelwood, CO, US

Download summary PDF View on FDA.gov ↗

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