LEADCARE BLOOD LEAD TESTING SYSTEM— 510(k) K971640
Substantially EquivalentEsa, Inc.
FDA 510(k) clearance K971640 for LEADCARE BLOOD LEAD TESTING SYSTEM, Substantially Equivalent on 1997-09-09. Applicant: Esa, Inc.. Device class: 2.
Clearance details
- Applicant
- Esa, Inc.
- Product code
- Code DOF
- Device class
- Class 2
- Regulation
- 21 CFR 862.3550
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chelmsford, MA, US
Recent devices under product code DOF
view allMore clearances from Esa, Inc.
view allRecalls naming K971640
K-number listed on FDA's recall record- Z-0285-2019 — Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and treatment reagent of the test kit are specific for lead only. Contents of the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.
- Z-2225-2017 — Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971640.
Data sourced from openFDA. This site is unofficial and independent of the FDA.