Il Phoenix(Tm), Model 905 Chem/Elect Analyzer
FDA 510(k) K912016 · Instrumentation Laboratory CO
510(k) numberK912016
Submission
- Device name
- Il Phoenix(Tm), Model 905 Chem/Elect Analyzer
- Applicant
- Instrumentation Laboratory CO
Lexington, MA, US - Received
- May 3, 1991
- Decision date
- June 10, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K252475 | ABL90 FLEX PLUS SystemJGS · Traditional | Radiometer Medicals Aps | 05/01/2026SE |
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl)JGS · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2023SE |
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerJGS · Traditional | Beckman Coulter Laboratory Systems (Suzhou) Co.… | 07/20/2023SE |
| K213486 | GLP systems TrackJGS · Traditional | Abbott Laboratories | 03/10/2022SE |
| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 04/14/2020SE |
| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 07/19/2019SE |
| K172232 | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600JGS · Traditional | Ams Diagnostics | 06/12/2019SE |
| K183549 | GEM Premier ChemSTATJGS · Traditional | Instrumentation Laboratory CO | 02/16/2019SE |
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| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
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Questions and answers
When was Il Phoenix(Tm), Model 905 Chem/Elect Analyzer cleared by the FDA?
Il Phoenix(Tm), Model 905 Chem/Elect Analyzer (K912016) received a 510(k) decision of Substantially Equivalent on June 10, 1991, 38 days after the submission was received.
What is the product code of K912016?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.