510(k) K173403
- Device
- GEM Premier 5000
- Applicant
- Instrumentation Laboratory Co.
- 510(k) number
- K173403
- Product code
- CHL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-12-29
- Date received
- 2017-10-31
- Regulation
- 862.1120
- Classification name
- Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
- 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
- Carol Marble
- Address
- 180 Hartwell Rd. Bedford MA US 01730 01730
FDA Registration Numbers#
- 3006198300
- 2431530
- 9610633
- 3003795116
- 1181121
- 8030478
- 2050012
- 2432235
- 1217183
- 3003971136
- 3012104670
- 1036362
- 3004959793
- 3007662974
- 1717966
- 3005643513
- 3002637618
- 3002807968
- 3007490412
- 2245578
- 3015997711
- 3037000637
- 3012817228
- 3013513377
- 1222035
- 1220649
- 1219913
- 9610126
- 1220972
- 3023162659
- 1219029
- 3004102403
- 3014506106
- 1000455123
Source Documents#
Other 510(k) Records For Product Code CHL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | 2026-04-10 |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2025-05-02 |
| K240998 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2024-12-13 |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-10-27 |
| K221900 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2023-09-29 |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-09-15 |
| K223608 | GEM Premier 7000 with IQM3 | Instrumentation Laboratory Company | 2023-08-10 |
| K211559 | EasyStat 300 | Medica Corporation | 2023-01-27 |
| K203790 | GEM Premier 5000 | Instrumentation Laboratory CO | 2021-08-20 |
| K200986 | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. | 2021-08-02 |
| K200107 | epoc Blood Analysis System | Epocal, Inc. | 2020-06-05 |
| K200492 | i-STAT CG4+ Cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-04-09 |
| K192240 | RAPIDPoint 500e Blood Gas System | Siemens Healthcare Diagnostics, Inc. | 2020-03-27 |
| K193246 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020-01-24 |
| K173797 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-07-17 |
Legacy Summary#
summary
FDA Review#
Decision Summary