Sensi-Cal Amco AEPA-1
FDA 510(k) K935566 · Radiometer America, Inc.
510(k) numberK935566
Submission
- Device name
- Sensi-Cal Amco AEPA-1
- Applicant
- Radiometer America, Inc.
Westlake, OH, US - Received
- November 18, 1993
- Decision date
- March 29, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K110331 | Sensititre Aim (TM)LIE · Traditional | Trek Diagnostic Systems, Ltd. | 04/27/2011SE |
| 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 Sensi-Cal Amco AEPA-1 cleared by the FDA?
Sensi-Cal Amco AEPA-1 (K935566) received a 510(k) decision of Substantially Equivalent on March 29, 1994, 131 days after the submission was received.
What is the product code of K935566?
The FDA product code is LIE – Reagent/Device, Inoculum Calibration, a Class II (moderate risk) device regulated under 21 CFR 866.1640.