510(k) K160370 ยท JGS Electrode, Ion Specific, Sodium
BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jun 9, 2016 |
| Received | Feb 10, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2019 | Mindray DS USA, Inc. dba Mindray North America BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (0 Terminated |
JGS | None listed |
| Dec 9, 2019 | Mindray DS USA, Inc. dba Mindray North America ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear s Terminated |
JGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.