ACCURATE I— 510(k) K812261
Substantially EquivalentOrganon, Inc.
FDA 510(k) clearance K812261 for ACCURATE I, Substantially Equivalent on 1981-08-31. Applicant: Organon, Inc.. Device class: 2.
Clearance details
- Applicant
- Organon, Inc.
- Product code
- Code JHJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code JHJ
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