ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS— 510(k) K973707
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K973707 for ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS, Substantially Equivalent on 1999-08-04. Applicant: Roche Molecular Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Roche Molecular Systems, 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
- Branchburg, NJ, US
Recent devices under product code MKZ
view allMore clearances from Roche Molecular Systems, Inc.
view all- K260045 — cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190) +1 more
- K260047 — cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) +1 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.