← Back to catalogue
Qualicheck5+ (S7730 +3 more) - S7750
FDA 510(k)Class I (US FDA 510(k))
510(k) K980135
Identifiers
- 510(k) Number
- K980135 FDA 510(k)
- FDA Product Code
- JJS FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1660 FDA 510(k)
- Regulation Number
- 862.1660 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Qualicheck5+ (S7730 +3 more) - S7750 by Radiometer America, Inc. — Class I — FDA_510K — listed in FDA 510(k) — 4 models — 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 | K980135 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Radiometer America, Inc.
Sources (1)
- FDA 510(k) K980135 24 fields · synced Jun 18, 2026