ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY— 510(k) K980716
Substantially EquivalentNichols Institute Diagnostics
FDA 510(k) clearance K980716 for ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY, Substantially Equivalent on 1998-04-03. Applicant: Nichols Institute Diagnostics. Device class: 2.
Clearance details
- Applicant
- Nichols Institute Diagnostics
- 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
- San Juan Capistrano, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.