510(k) K160370
- Device
- 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
- 510(k) number
- K160370
- Product code
- JGS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-06-09
- Date received
- 2016-02-10
- Regulation
- 862.1665
- Classification name
- Electrode, Ion Specific, Sodium
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Zeng Zhe
- Address
- Mindray Bldg., Keji 12th Rd. South, Hi-Tech Industrial Park Shenzhen CN 518057 518057
FDA Registration Numbers#
- 9612296
- 2030861
- 3006198300
- 9610633
- 3000126629
- 1220649
- 3010825766
- 3002807968
- 8020888
- 1219029
- 3004438098
- 3016244760
- 3037000637
- 3005509212
- 3004378326
- 1000455123
- 2431530
- 1717966
- 3007603826
- 1317202
- 2050010
- 8030478
- 3014506106
- 3003971136
- 3016438761
- 3013513377
- 1319436
- 3000308930
- 3023162659
- 1220972
- 3000148879
- 3003593973
- 3012817228
- 3003795116
- 1217183
- 3003637681
- 3004102403
- 3002637618
- 3012104670
- 3007490412
- 3004959793
- 2432235
- 8020316
- 3005333358
- 3004493545
- 9680746
- 3011989923
- 2085064
- 3003030793
- 1616487
- 3002809144
- 3002642396
- 2221819
- 1319809
- 3010324880
- 1181121
- 9614673
- 3012963943
- 2245578
- 2250051
- 1222035
- 2247288
- 2050012
- 3009473156
- 9610529
- 3015997711
- 3014607865
- 3008244372
- 3005643513
- 1036223
- 2517506
- 1000414342
- 9610816
- 9610126
- 1036362
- 3023268435
- 2939693
- 3009156722
- 1000256526
- 1827821
Source Documents#
Other 510(k) Records For Product Code JGS #
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| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl) | Siemens Healthcare Diagnostics, Inc. | 2023-07-25 |
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023-07-20 |
| K213486 | GLP systems Track | Abbott Laboratories | 2022-03-10 |
| K200403 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020-04-14 |
| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-02-07 |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer System | Nova Biomedical Corporation | 2019-07-19 |
| K172232 | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 | Ams Diagnostics | 2019-06-12 |
| K183549 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019-02-16 |
| K180428 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-08-15 |
| K181201 | Synermed ISE Reagents | Infrared Laboratory Systems, LLC (Dba Synermed) | 2018-07-10 |
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) | Awareness Technology, Inc. | 2018-02-27 |
| K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics | 2017-03-09 |
| K161837 | ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer | Beckman Coulter, Inc. | 2016-12-16 |
Legacy Summary#
summary
FDA Review#
Decision Summary