V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control— 510(k) K192931
Substantially EquivalentHelena Laboratories, Corp.
FDA 510(k) clearance K192931 for V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control, Substantially Equivalent on 2022-04-19. Applicant: Helena Laboratories, Corp.. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories, Corp.
- Product code
- Code GKA
- Device class
- Class 2
- Regulation
- 21 CFR 864.7415
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
Recent devices under product code GKA
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