FETAL CHECK— 510(k) K792546
Substantially EquivalentAlta Diagnostics, Inc.
FDA 510(k) clearance K792546 for FETAL CHECK, Substantially Equivalent on 1979-12-18. Applicant: Alta Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Alta Diagnostics, Inc.
- Product code
- Code KJR
- Device class
- Class 1
- Regulation
- 21 CFR 864.1850
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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