ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions— 510(k) K253491
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K253491 for ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions, Substantially Equivalent on 2026-02-12. Applicant: Roche Diagnostics. Device class: 2.
Summary
Roche Diagnostics lists ISE indirect K, Na, and Cl for Gen.2, plus cobas pro integrated solutions, under product code CEM (Electrode, Ion Specific, Potassium). The record doesn't describe them beyond those names and that code name.
Class II, 21 CFR 862.1600. Clinical Chemistry is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Roche Diagnostics filed from Indianapolis, Indiana. The substantially equivalent decision came 111 calendar days after receipt (October 24, 2025 to February 12, 2026).
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Product code CEM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CEM
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