HEMOCUE B-HEMOGLOBIN SYSTEM— 510(k) K961312
Substantially EquivalentHemocue, Inc.
FDA 510(k) clearance K961312 for HEMOCUE B-HEMOGLOBIN SYSTEM, Substantially Equivalent on 1996-09-24. Applicant: Hemocue, Inc.. Device class: 2.
Clearance details
- Applicant
- Hemocue, Inc.
- Product code
- Code GKR
- Device class
- Class 2
- Regulation
- 21 CFR 864.5620
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Potomac, MD, US
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