510(k) K935566
- Device
- SENSI-CAL AMCO AEPA-1
- Applicant
- RADIOMETER AMERICA, INC.
- 510(k) number
- K935566
- Product code
- LIE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-03-29
- Date received
- 1993-11-18
- Regulation
- 866.1640
- Classification name
- Reagent/device, Inoculum Calibration
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JENNIFER LORBACH
- Address
- 811 Sharon Dr. Westlake OH US 44145 44145
FDA Registration Numbers#
- 1530126
- 8021914
- 1924669
- 3009840089
- 2919016
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LIE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221493 | MicroScan Prompt Inoculation System-D | Beckman Coulter, Inc. | 2023-04-05 |
| K103456 | THE SENSITITRE AIM | Trek Diagnostic Systems | 2011-06-22 |
| K110331 | SENSITITRE AIM (TM) | Trek Diagnostic Systems, Ltd. | 2011-04-27 |
| K911059 | TURBIDOMETRIC STANDARD | Scientific Device Laboratory, Inc. | 1991-06-10 |
| K890339 | DIFCO DIRECTOR INOCULATION SYSTEM | Difco Laboratories, Inc. | 1989-02-07 |
| K820299 | PROMPT INOCULATION SYSTEM | 3M Company | 1982-03-15 |
Legacy Summary#
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FDA Review#
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