Identifiers
- 510(k) Number
- K834065 FDA 510(k)
- FDA Product Code
- JSN FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.2390 FDA 510(k)
- Regulation Number
- 866.2390 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The A3B medical device is a culture media and propagating transport system used in microbiology testing. This FDA-approved device has been substantially equivalent to other similar products on the market, providing accurate and reliable results for healthcare professionals. With its traditional clearance type and advisory committee of microbiologists, the A3B device meets all regulatory requirements for its intended use.
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 | K834065 | Class I | Active |
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Manufacturer
- Manufacturer
- Remel Co.
Sources (1)
- FDA 510(k) K834065 24 fields · synced Jun 21, 2026