MicroScan Prompt Inoculation System-D
FDA 510(k) K221493 · Beckman Coulter, Inc.
510(k) numberK221493
Submission
- Device name
- MicroScan Prompt Inoculation System-D
- Applicant
- Beckman Coulter, Inc.
West Sacramento, CA, US - Received
- May 23, 2022
- Decision date
- April 5, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIE – Reagent/Device, Inoculum Calibration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
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| K103456 | The Sensititre AimLIE · Traditional | Trek Diagnostic Systems | 06/22/2011SE |
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| K935566 | Sensi-Cal Amco AEPA-1LIE · Traditional | Radiometer America, Inc. | 03/29/1994SE |
| K911059 | Turbidometric StandardLIE · Traditional | Scientific Device Laboratory, Inc. | 06/10/1991SE |
| K890339 | Difco Director Inoculation SystemLIE · Traditional | Difco Laboratories, Inc. | 02/07/1989SE |
| K820299 | Prompt Inoculation SystemLIE · Traditional | 3M Company | 03/15/1982SE |
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Questions and answers
When was MicroScan Prompt Inoculation System-D cleared by the FDA?
MicroScan Prompt Inoculation System-D (K221493) received a 510(k) decision of Substantially Equivalent on April 5, 2023, 317 days after the submission was received.
What is the product code of K221493?
The FDA product code is LIE – Reagent/Device, Inoculum Calibration, a Class II (moderate risk) device regulated under 21 CFR 866.1640.