HEMAPROMPT— 510(k) K972763
Substantially EquivalentAerscher Diagnostics
FDA 510(k) clearance K972763 for HEMAPROMPT, Substantially Equivalent on 1997-10-20. Applicant: Aerscher Diagnostics. Device class: 2.
Clearance details
- Applicant
- Aerscher Diagnostics
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chestertown, MD, US
Recent devices under product code KHE
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