FDA Registration
Inactive
🇺🇸 United States
AUTONOMOUS MEDICAL DEVICES INCORPORATED
·
Expires 2026
Products
5
Proprietary Names
4
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- AUTONOMOUS MEDICAL DEVICES INCORPORATED
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3511 W Sunflower Ave
- City
- Santa Ana
- State
- CA
- ZIP
- 92704
- Country
- US
Regulatory Submissions
- 510(k) Number
- K252932
Owner / Operator
- Firm Name
- Autonomous Medical Devices Incorporated
- Operator Number
- 10096063
- Address
- 3511 W. Sunflower Avenue
- City
- Santa Ana
- State
- CA
- Postal Code
- 92704
- Country
- US
- Correspondent
- Aiying Sun
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | PMN | Class 2 | Microbiology | No | 2026-06-16 |
| Respiratory Virus Panel Nucleic Acid Assay System | OCC | Class 2 | Microbiology | No | 2026-06-16 |
| Influenza A And Influenza B Multiplex Nucleic Acid Assay | OZE | Class 2 | Microbiology | No | 2026-06-16 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2026-06-16 |
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | Class 2 | Microbiology | No | 2026-06-16 |
Proprietary Names
Fast PCR Instrument
Fast PCR Mini Respiratory Panel Negative External Control
Fast PCR Mini Respiratory Panel Positive External Control
Fast PCR Mini Respiratory Panel
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device