← Back to catalogue
AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS - Roche Scripts For Ct/Ng Test Accessory
FDA 510(k)Class I (US FDA 510(k))
510(k) K070174
Identifiers
- 510(k) Number
- K070174 FDA 510(k)
- FDA Product Code
- MKZ FDA 510(k)
- Models / Variants
- Roche Scripts For Ct/Ng Test Accessory FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3120 FDA 510(k)
- Regulation Number
- 866.3120 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS - Roche Scripts For Ct/Ng Test Accessory by Roche Diagnostics Corporation — Class I — FDA_510K — listed in FDA…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070174 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corporation
Sources (1)
- FDA 510(k) K070174 24 fields · synced Jun 18, 2026