Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions— 510(k) K253490
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K253490 for Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions, Substantially Equivalent on 2026-02-12. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CFR
view all- K252357 — Glucose2
- K220134 — cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
- K191899 — Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
- K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
- K153644 — ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
More clearances from Roche Diagnostics
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