APTIMA COMBO 2 ASSAY— 510(k) K111409
Substantially EquivalentGen-Probe, Inc.
FDA 510(k) clearance K111409 for APTIMA COMBO 2 ASSAY, Substantially Equivalent on 2012-05-03. Applicant: Gen-Probe, Inc.. Device class: 2.
Clearance details
- Applicant
- Gen-Probe, Inc.
- Product code
- Code LSL
- Device class
- Class 2
- Regulation
- 21 CFR 866.3390
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.