PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS— 510(k) K060768
Substantially EquivalentAbbott Diabetes Care, Inc.
FDA 510(k) clearance K060768 for PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS, Substantially Equivalent on 2006-04-21. Applicant: Abbott Diabetes Care, Inc.. Device class: 1.
Clearance details
- Applicant
- Abbott Diabetes Care, Inc.
- Product code
- Code JIN
- Device class
- Class 1
- Regulation
- 21 CFR 862.1435
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Alameda, CA, US
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More clearances from Abbott Diabetes Care, Inc.
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- K222447 — FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System
- K223537 — FreeStyle Libre 2 System, FreeStyle Libre 3 System
- K212132 — FreeStyle Libre 3 Continuous Glucose Monitoring System
Recalls naming K060768
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 K060768.
Data sourced from openFDA. This site is unofficial and independent of the FDA.