← Back to catalogue
Anti-Skin Antibody Test(monkey Esophagus Sections)
FDA 510(k)Class II (US FDA 510(k))
510(k) K891098
Identifiers
- 510(k) Number
- K891098 FDA 510(k)
- FDA Product Code
- DBL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5660 FDA 510(k)
- Regulation Number
- 866.5660 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Anti-Skin Antibody Test(monkey Esophagus Sections) by Immco Diagnostics, Inc. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
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 | K891098 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immco Diagnostics, Inc.
Sources (1)
- FDA 510(k) K891098 24 fields · synced Sep 17, 2026