Identifiers
- 510(k) Number
- K864464 FDA 510(k)
- FDA Product Code
- JFJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1070 FDA 510(k)
- Regulation Number
- 862.1070 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Psi Amylase Reagent by Pointe Scientific, 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 | K864464 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
- FDA Applicant
- Pointe Scientific, Inc.,
Sources (1)
- FDA 510(k) K864464 24 fields · synced Jun 19, 2026