BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit— 510(k) K180438
Substantially EquivalentBd
FDA 510(k) clearance K180438 for BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit, Substantially Equivalent on 2018-03-20. Applicant: Bd. Device class: 2.
Clearance details
- Applicant
- Bd
- Product code
- Code PSZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3328
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Recent devices under product code PSZ
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view all- K253445 — BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)
- K240257 — Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit
- K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
- K221504 — BD Surgiphor Antimicrobial Irrigation System
- K024240 — BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
Recalls naming K180438
K-number listed on FDA's recall record- Z-0630-2022 — BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
- Z-1313-2019 — BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180438.
Data sourced from openFDA. This site is unofficial and independent of the FDA.