cobas MRSA/SA Test— 510(k) K142721
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K142721 for cobas MRSA/SA Test, Substantially Equivalent on 2014-12-17. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code NQX
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code NQX
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- K260021 — cobas® BV/CV
- K260917 — cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
- K253756 — cobas liat CT/NG nucleic acid test
Recalls naming K142721
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142721.
Data sourced from openFDA. This site is unofficial and independent of the FDA.