NEW ALLERG. COATED MICROFILTER WELL STRI

System, Test, Radioallergosorbent (rast) Immunological

DIAGNOSTIC REAGENT TECH.

The following data is part of a premarket notification filed by Diagnostic Reagent Tech. with the FDA for New Allerg. Coated Microfilter Well Stri.

Pre-market Notification Details

Device IDK843302
510k NumberK843302
Device Name:NEW ALLERG. COATED MICROFILTER WELL STRI
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant DIAGNOSTIC REAGENT TECH. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-23
Decision Date1984-10-04

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