Access PCT, Access PCT Calibrators— 510(k) K192271
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K192271 for Access PCT, Access PCT Calibrators, Substantially Equivalent on 2019-11-26. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code PTF
- Device class
- Class 2
- Regulation
- 21 CFR 866.3215
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code PTF
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view allRecalls naming K192271
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 K192271.
Data sourced from openFDA. This site is unofficial and independent of the FDA.