Day

February 28, 2001
Date of enforcement report: 2/28/01Date of recall: 9/12/00 Company: Escreen Inc. Class: II PRODUCT: EScreen System, which collectively includes the eCUP, the eREADER optical imaging technology, and the eCUP data analysis software, for use in drug abuse testing. Recall #Z-205-1. REASON: Distributed without 510(k) clearance. CODE: All. MANUFACTURER: EScreen Inc., Overland Park, KS. RECALLED BY:...
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FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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