LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901— 510(k) K003583
Substantially EquivalentTrace America, Inc.
FDA 510(k) clearance K003583 for LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901, Substantially Equivalent on 2001-01-17. Applicant: Trace America, Inc.. Device class: 2.
Clearance details
- Applicant
- Trace America, Inc.
- Product code
- Code NDW
- Device class
- Class 2
- Regulation
- 21 CFR 862.3560
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arlington, TX, US
Recent devices under product code NDW
view allMore clearances from Trace America, Inc.
view all- K980026 — GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
- K980028 — ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
- K980030 — AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
- K973869 — TRACE REAGENT LINE FOR THE COBAS MIRA
- K974620 — AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
Data sourced from openFDA. This site is unofficial and independent of the FDA.