HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED— 510(k) K881477
Substantially EquivalentStat Path
FDA 510(k) clearance K881477 for HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED, Substantially Equivalent on 1988-04-18. Applicant: Stat Path. Device class: 1.
Clearance details
- Applicant
- Stat Path
- Product code
- Code KEL
- Device class
- Class 1
- Regulation
- 21 CFR 864.4010
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Riderwood, MD, US
Recent devices under product code KEL
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