Clinak(Tm) Ise Subsystem
FDA 510(k) K910554 · Baxter Healthcare Corp
510(k) numberK910554
Submission
- Device name
- Clinak(Tm) Ise Subsystem
- Applicant
- Baxter Healthcare Corp
Santa Ana, CA, US - Received
- January 31, 1991
- Decision date
- March 6, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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Questions and answers
When was Clinak(Tm) Ise Subsystem cleared by the FDA?
Clinak(Tm) Ise Subsystem (K910554) received a 510(k) decision of Substantially Equivalent on March 6, 1991, 34 days after the submission was received.
What is the product code of K910554?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.