THE THERATEST ACA TEST— 510(k) K905301
Substantially EquivalentTheratest Laboratories, Inc.
FDA 510(k) clearance K905301 for THE THERATEST ACA TEST, Substantially Equivalent on 1991-01-14. Applicant: Theratest Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Theratest Laboratories, Inc.
- Product code
- Code GFO
- Device class
- Class 2
- Regulation
- 21 CFR 864.7925
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Recent devices under product code GFO
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Data sourced from openFDA. This site is unofficial and independent of the FDA.