ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM— 510(k) K170316
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K170316 for ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM, Substantially Equivalent on 2017-10-19. Applicant: Abbott Laboratories. Device class: 2.
Clearance details
- Applicant
- Abbott Laboratories
- 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
- Abbott Park, IL, US
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More clearances from Abbott Laboratories
view allRecalls naming K170316
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170316.
Data sourced from openFDA. This site is unofficial and independent of the FDA.