METACHROME— 510(k) K851174
Substantially EquivalentPotomac Medical System
FDA 510(k) clearance K851174 for METACHROME, Substantially Equivalent on 1985-05-23. Applicant: Potomac Medical System. Device class: 2.
Clearance details
- Applicant
- Potomac Medical System
- Product code
- Code LNJ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5260
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Silver Spring, MD, US
Recent devices under product code LNJ
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