DIGITAL-9 KEY LEUCOCYTE COUNTER— 510(k) K854685
Substantially EquivalentFuture Impex Corp.
FDA 510(k) clearance K854685 for DIGITAL-9 KEY LEUCOCYTE COUNTER, Substantially Equivalent on 1986-04-04. Applicant: Future Impex Corp.. Device class: 1.
Clearance details
- Applicant
- Future Impex Corp.
- Product code
- Code GKM
- Device class
- Class 1
- Regulation
- 21 CFR 864.6160
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deerpark, NY, US
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