ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE— 510(k) K974503
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K974503 for ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE, Substantially Equivalent on 1999-12-01. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Product 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
- Branchburg, NJ, US
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