HYDRAGAMMA 16— 510(k) K800601
Substantially EquivalentInnotron of Oregon, Inc.
FDA 510(k) clearance K800601 for HYDRAGAMMA 16, Substantially Equivalent on 1980-04-10. Applicant: Innotron of Oregon, Inc.. Device class: 1.
Clearance details
- Applicant
- Innotron of Oregon, Inc.
- Product code
- Code JJJ
- Device class
- Class 1
- Regulation
- 21 CFR 862.2320
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JJJ
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