510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K160370Substantially Equivalent

BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer

Shenzhen Mindray Bio-Medical Electronics Co.,LTD, Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160370 is the FDA 510(k) clearance record for BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer, a class II device, cleared for Shenzhen Mindray Bio-Medical Electronics Co., Ltd. on under FDA product code JGS (Electrode, Ion Specific, Sodium). FDA records list 160 510(k) clearances for Shenzhen Mindray Bio-Medical Electronics Co., Ltd., from to . As of , FDA records show 2 recalls naming K160370.

Clearance record

Decision date
Received
(120 days to decision)
Product code
JGS Electrode, Ion Specific, Sodium
Regulation
21 CFR 862.1665
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Bldg., Keji 12th Rd., Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JGS

Trailing 12 months
1 clearance under product code JGS in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JGS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260