ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY— 510(k) K960274
Substantially EquivalentOrgentec
FDA 510(k) clearance K960274 for ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY, Substantially Equivalent on 1996-03-29. Applicant: Orgentec. Device class: 1.
Clearance details
- Applicant
- Orgentec
- Product code
- Code JIR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1645
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Windham, NH, US
Recent devices under product code JIR
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