DeviceClearance

BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer— 510(k) K160370

Substantially Equivalent

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

FDA 510(k) clearance K160370 for BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer, Substantially Equivalent on 2016-06-09. Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Product code
Code JGS
Device class
Class 2
Regulation
21 CFR 862.1665
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shenzhen, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JGS

product code JGS
Malfunction
535
Total
535

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K160370

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160370.

Data sourced from openFDA. This site is unofficial and independent of the FDA.