Media, Potentiating For In Vitro Diagnostic Use

Media, Potentiating For In Vitro Diagnostic Use

Amtec Diagnostics International Inc.

The following data is part of a premarket notification filed by Amtec Diagnostics International Inc. with the FDA for Media, Potentiating For In Vitro Diagnostic Use.

Pre-market Notification Details

Device IDBK860002
510k NumberBK860002
Device Name:Media, Potentiating For In Vitro Diagnostic Use
ClassificationMedia, Potentiating For In Vitro Diagnostic Use
Applicant Amtec Diagnostics International Inc. 1107 Ih-45 South Conroe,  TX  77305
Product CodeKSG  
CFR Regulation Number864.9600 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-09
Decision Date1986-03-03

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