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A1cnow+ (10 Test Kit, Professional Use) (3024 +3 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K090413
Identifiers
- 510(k) Number
- K090413 FDA 510(k)
- FDA Product Code
- LCP FDA 510(k)
- Models / Variants
- 3024 FDA 510(k)A1cnow+(20 Test Kit FDA 510(k)Professional Use) Model 3021 FDA 510(k)A1cnow Self Chec FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7470 FDA 510(k)
- Regulation Number
- 864.7470 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A1cnow+ (10 Test Kit, Professional Use) (3024 +3 more) by Bayer HealthCare, LLC — Class II — FDA_510K — listed in FDA 510(k) — 4 models
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 | K090413 | Class II | Active |
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Manufacturer
- Manufacturer
- Bayer HealthCare, LLC
Sources (1)
- FDA 510(k) K090413 24 fields · synced Jun 18, 2026