Product code DOF
- Device name
- Lead, Atomic Absorption
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3550
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142705 | LeadCare Plus Blood Lead Testing System | Magellan Diagnostics | 2015-07-07 |
| K123563 | LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM | Magellan Diagnostics | 2013-08-20 |
| K052549 | LEADCARE II BLOOD LEAD TESTING SYSTEM | Esa Biosciences, Inc. | 2005-10-06 |
| K971640 | LEADCARE BLOOD LEAD TESTING SYSTEM | Esa, Inc. | 1997-09-09 |
| K936060 | ATOMSPEC GF BLOOD LEAD WORKSTATION | Thermo Jarrell Ash Corp.Div.Thermo Inst. | 1994-09-06 |
| K843839 | STAT/PB REAGENT | Tri-Tech, Inc. | 1985-01-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850355006185 | LeadCare® Plus Blood Lead Analyzer Kit | MAGELLAN DIAGNOSTICS, INC. | 2018-10-22 |
| 00850355006086 | LeadCare® II 5X Test Kit | MAGELLAN DIAGNOSTICS, INC. | 2018-10-22 |
| 00850355006178 | LeadCare® II Blood Lead Analyzer Kit, Refurbished | MAGELLAN DIAGNOSTICS, INC. | 2016-09-20 |
| 00850355006161 | LeadCare® Blood Lead Control Kit | MAGELLAN DIAGNOSTICS, INC. | 2016-09-20 |
| 00850355006130 | LeadCare® Heparinized Capillary Tubes | MAGELLAN DIAGNOSTICS, INC. | 2016-09-20 |
| 00850355006017 | LeadCare® II Blood Lead Analyzer Kit | MAGELLAN DIAGNOSTICS, INC. | 2016-09-19 |
| 00850355006154 | LeadCare® Blood Lead Test Kit | MAGELLAN DIAGNOSTICS, INC. | 2016-09-19 |
| 00850355006147 | LeadCare® Blood Collection Plungers | MAGELLAN DIAGNOSTICS, INC. | 2016-09-19 |
| 00850355006123 | LeadCare® II Replacement AC Adapter and Plug Set | MAGELLAN DIAGNOSTICS, INC. | 2016-09-19 |
| 00850355006116 | LeadCare® Plus Data ManagementSystem | MAGELLAN DIAGNOSTICS, INC. | 2016-09-19 |
| 00850355006079 | LeadCare® II Blood Lead 6 Tests Kit | MAGELLAN DIAGNOSTICS, INC. | 2016-09-19 |
| 00850355006062 | LeadCare® Plus Blood Lead Analyzer Kit | MAGELLAN DIAGNOSTICS, INC. | 2016-09-19 |
| 00850355006000 | LeadCare® II Blood Lead Test Kit | MAGELLAN DIAGNOSTICS, INC. | 2016-09-19 |
| 00850355006109 | LeadCare® II Blood Lead Testing System 9X ClinicalTest Kit | MAGELLAN DIAGNOSTICS, INC. | 2016-09-09 |
| 00850355006093 | LeadCare® II Blood Lead Testing System 9X Test Kit | MAGELLAN DIAGNOSTICS, INC. | 2016-09-09 |
| 00850355006055 | LeadCare® Ultra Blood Lead Testing System | MAGELLAN DIAGNOSTICS, INC. | 2016-09-09 |
| 00850355006048 | LeadCare® Ultra Blood Lead Analyzer Kit | MAGELLAN DIAGNOSTICS, INC. | 2016-09-09 |
| 00850355006031 | LeadCare® Plus Blood Lead Test Kit | MAGELLAN DIAGNOSTICS, INC. | 2016-09-09 |
| 00850355006024 | LeadCare® Ultra Blood Lead Test Kit | MAGELLAN DIAGNOSTICS, INC. | 2016-09-09 |