BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
FDA 510(k) clearance K991074 · decided 1999-12-21
Clearance details
- K-number
- K991074
- Device name
- BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
- Applicant
- Intracel Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-31
- Decision date
- 1999-12-21
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- MJH
- Device class
- 2
- Regulation number
- 866.3300
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic tes recall (Z-2292-2025) | Trinity Biotech USA | 2025-08-12 |