APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM— 510(k) K061413
Substantially EquivalentGen-Probe, Inc.
FDA 510(k) clearance K061413 for APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM, Substantially Equivalent on 2006-10-13. Applicant: Gen-Probe, Inc.. Device class: 1.
Clearance details
- Applicant
- Gen-Probe, Inc.
- Product code
- Code MKZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3120
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code MKZ
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