SENSI-CAL AMCO AEPA-1— 510(k) K935566
Substantially EquivalentRadiometer America, Inc.
FDA 510(k) clearance K935566 for SENSI-CAL AMCO AEPA-1, Substantially Equivalent on 1994-03-29. Applicant: Radiometer America, Inc.. Device class: 2.
Clearance details
- Applicant
- Radiometer America, Inc.
- Product code
- Code LIE
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westlake, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.