BS-200 CHEMISTRY ANALYZER, MODE BS-200— 510(k) K072018
Substantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.
FDA 510(k) clearance K072018 for BS-200 CHEMISTRY ANALYZER, MODE BS-200, Substantially Equivalent on 2008-02-01. Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
Recent devices under product code CFR
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- K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
More clearances from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
view all- K253330 — A5 Anesthesia System (A5); A7 Anesthesia System (A7)
- K260098 — ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
- K260846 — Diagnostic Ultrasound System (13+ models)
- K253170 — uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
- K252182 — SV70 Ventilator (SV70)
Recalls naming K072018
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072018.
Data sourced from openFDA. This site is unofficial and independent of the FDA.