DIA REPTIN— 510(k) K841365
Substantially EquivalentDiatech, Inc.
FDA 510(k) clearance K841365 for DIA REPTIN, Substantially Equivalent on 1984-06-01. Applicant: Diatech, Inc.. Device class: 1.
Clearance details
- Applicant
- Diatech, Inc.
- Product code
- Code GIR
- Device class
- Class 1
- Regulation
- 21 CFR 864.8950
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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