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 ID: K820299
• 510k Number: K820299
• Device Name: PROMPT INOCULATION SYSTEM
• Classification: Reagent/device, Inoculum Calibration
• Applicant: 3M COMPANY 8124 PACIFIC AVE. White City, OR 97503
• Product Code: LIE
• CFR Regulation Number: 866.1640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-02-04
• Decision Date: 1982-03-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30382902263068	K820299	000
15099590659561	K820299	000