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

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

510(k) K160370

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160370 Date9 Jun 2016ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0920-2020 FDA Class II initiated 9 Dec 2019
    • Terminated Z-0921-2020 FDA Class II initiated 9 Dec 2019

    The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JGS
Device Class
Class II
Regulation
21 CFR Part 862.1665
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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