POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE

Ige, Peroxidase, Antigen, Antiserum, Control

DIAGNOSTIC REAGENT TECH.

The following data is part of a premarket notification filed by Diagnostic Reagent Tech. with the FDA for Polystyrene Micro-liter Plate-birchtree.

Pre-market Notification Details

Device IDK831984
510k NumberK831984
Device Name:POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE
ClassificationIge, Peroxidase, Antigen, Antiserum, Control
Applicant DIAGNOSTIC REAGENT TECH. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDGO  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-06-20
Decision Date1983-11-21

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