Submission Details
| 510(k) Number | K820299 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 04, 1982 |
| Decision Date | March 15, 1982 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
Cleared
Traditional
PROMPT INOCULATION SYSTEM
Mar 1982
Decision
39d
Days
Class 2
Risk
About This 510(k) Submission
K820299 is an FDA 510(k) clearance for the PROMPT INOCULATION SYSTEM, a Reagent/device, Inoculum Calibration (Class II — Special Controls, product code LIE), submitted by 3M Company (White City, US). The FDA issued a Cleared decision on March 15, 1982, 39 days after receiving the submission on February 4, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.
Device Classification
| Product Code | LIE — Reagent/device, Inoculum Calibration |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.1640 |
Manufacturer
Similar Devices — LIE Reagent/device, Inoculum Calibration
K221493 · Beckman Coulter, Inc.
· Apr 2023
K103456 · Trek Diagnostic Systems
· Jun 2011
K110331 · Trek Diagnostic Systems, Ltd.
· Apr 2011
K935566 · Radiometer America, Inc.
· Mar 1994
K911059 · Scientific Device Laboratory, Inc.
· Jun 1991
K890339 · Difco Laboratories, Inc.
· Feb 1989
More from 3M Company
View all
K243501
· FRC · Jan 2025
K242538
· FRC · Nov 2024
K241959
· FRC · Oct 2024
K241710
· FRC · Sep 2024
K240717
· FRC · Jun 2024