ERMA PC-604 BLOOD CELL COUNTER— 510(k) K854677
Substantially EquivalentFuture Impex Corp.
FDA 510(k) clearance K854677 for ERMA PC-604 BLOOD CELL COUNTER, Substantially Equivalent on 1986-02-24. Applicant: Future Impex Corp.. Device class: 2.
Clearance details
- Applicant
- Future Impex Corp.
- Product code
- Code GKL
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deerpark, NY, US
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