GLYCOMARK— 510(k) K031604
Substantially EquivalentTomen America, Inc.
FDA 510(k) clearance K031604 for GLYCOMARK, Substantially Equivalent on 2003-09-22. Applicant: Tomen America, Inc.. Device class: 2.
Clearance details
- Applicant
- Tomen America, Inc.
- Product code
- Code NOZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code NOZ
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