510(k) K100525
- Device
- ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
- Applicant
- SEPPIM S.A.S.
- 510(k) number
- K100525
- Product code
- CGA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-12-15
- Date received
- 2010-02-24
- Regulation
- 862.1345
- Classification name
- Glucose Oxidase, Glucose
- 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
- Debra Hutson
- Address
- 21720 23rd Dr. SE Suite 150 Bothell WA US 98021 98021
FDA Registration Numbers#
- 3007134734
- 9610633
- 3005621222
- 3011979858
- 3016525500
- 2939693
- 3010097171
- 9610126
- 3003422726
- 1827821
- 8040374
- 9615507
- 1220649
- 1000115322
- 3017550662
- 3002637618
- 9611444
- 3008789114
- 3022147580
- 3008780388
- 3010622184
- 3008959428
- 2030633
- 3009129531
- 3004193489
- 1832216
- 3045752480
- 3042301847
- 3003795116
- 3005643513
- 3021841051
- 3005862821
- 1319809
- 3004043187
- 3024512705
- 1219913
- 3003593973
- 1219029
- 1832816
- 9616530
- 1825396
- 3003674698
- 3005146313
- 1649661
- 2245578
- 3007662974
- 3045951983
- 3004102403
- 3013160357
- 3015347724
- 3010830834
- 2050010
- 3012133212
- 3007382160
- 3002736372
- 3005644014
- 3005146144
- 3030978471
- 3007490412
- 3003044483
- 3004183148
- 3004637226
- 3011213605
- 3002807968
- 3014506106
- 3007710663
- 3011065399
- 1066444
- 3030186688
- 2431530
- 3006198300
- 3037000637
- 3003589956
- 3015525148
- 3006532271
- 3003366417
- 9710595
- 3013957847
- 3009473156
- 3003917514
Source Documents#
Other 510(k) Records For Product Code CGA #
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|---|---|---|---|
| K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2026-05-01 |
| K210933 | YSI 2900C Biochemistry Analyzer | Ysi, Inc. | 2024-09-30 |
| K220328 | EasyStat 300 | Medica Corporation | 2024-07-26 |
| K223179 | Cholestech LDX ™ System | Alere San Diego, Inc. | 2023-09-20 |
| K223755 | i-STAT G cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-09-11 |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-07-28 |
| K223090 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2023-01-27 |
| K203549 | Nova Primary Glucose Analyzer System | Nova Biomedical Corporation | 2022-10-18 |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2021-08-13 |
| K200349 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020-03-13 |
| K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-02-07 |
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Ortho-Clinical Diagnostics, Inc. | 2019-04-03 |
| K183546 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019-02-16 |
| K182781 | PTS Professional Chemistry Kit | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2018-12-21 |
| K180340 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-09-26 |
Legacy Summary#
summary
FDA Review#
Decision Summary