PROMPT INOCULATION SYSTEM

Reagent/device, Inoculum Calibration

3M COMPANY

The following data is part of a premarket notification filed by 3m Company with the FDA for Prompt Inoculation System.

Pre-market Notification Details

Device IDK820299
510k NumberK820299
Device Name:PROMPT INOCULATION SYSTEM
ClassificationReagent/device, Inoculum Calibration
Applicant 3M COMPANY 8124 PACIFIC AVE. White City,  OR  97503
Product CodeLIE  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-02-04
Decision Date1982-03-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382902263068 K820299 000
15099590659561 K820299 000

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