BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST— 510(k) K991074
Substantially EquivalentIntracel Corp.
FDA 510(k) clearance K991074 for BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST, Substantially Equivalent on 1999-12-21. Applicant: Intracel Corp.. Device class: 2.
Clearance details
- Applicant
- Intracel Corp.
- Product code
- Code MJH
- Device class
- Class 2
- Regulation
- 21 CFR 866.3300
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Recent devices under product code MJH
view allMore clearances from Intracel Corp.
view allRecalls naming K991074
K-number listed on FDA's recall record- Z-2292-2025 — Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
- Z-0382-2022 — Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991074.
Data sourced from openFDA. This site is unofficial and independent of the FDA.