ACS:CENTAUR PSA2 IMMUNOASSAY— 510(k) K981839
Substantially EquivalentChiron Diagnostics Corp.
FDA 510(k) clearance K981839 for ACS:CENTAUR PSA2 IMMUNOASSAY, Substantially Equivalent on 1998-08-12. Applicant: Chiron Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Chiron Diagnostics Corp.
- Product code
- Code LTJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medfield, MA, US
Recent devices under product code LTJ
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