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Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-Xxxx
FDA 510(k)Class II (US FDA 510(k))
510(k) K011057
Identifiers
- 510(k) Number
- K011057 FDA 510(k)
- FDA Product Code
- PJD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1675 FDA 510(k)
- Regulation Number
- 862.1675 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-Xxxx by OraSure Technologies, Inc. — Class II — FDA_510K — listed in FDA 510(k)
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 | K011057 | Class II | Active |
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Manufacturer
- Manufacturer
- OraSure Technologies, Inc.
Sources (1)
- FDA 510(k) K011057 24 fields · synced Jun 18, 2026