LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
FDA 510(k) clearance K123563 · decided 2013-08-20
Clearance details
- K-number
- K123563
- Device name
- LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
- Applicant
- Magellan Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2012-11-19
- Decision date
- 2013-08-20
- Days to decision
- 274 days
- Clearance type
- Traditional
- Product code
- DOF
- Device class
- 2
- Regulation number
- 862.3550
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- N. Billerica, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LeadCare Plus Blood Lead Testing System (K142705) | Magellan Diagnostics | 2015-07-07 |
| LEADCARE II BLOOD LEAD TESTING SYSTEM (K052549) | Esa Biosciences, Inc. | 2005-10-06 |
| LEADCARE BLOOD LEAD TESTING SYSTEM (K971640) | Esa, Inc. | 1997-09-09 |
| ATOMSPEC GF BLOOD LEAD WORKSTATION (K936060) | Thermo Jarrell Ash Corp.Div.Thermo Inst. | 1994-09-06 |
| STAT/PB REAGENT (K843839) | Tri-Tech, Inc. | 1985-01-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 recall (Z-1954-2021) | Magellan Diagnostics, Inc. | 2021-07-01 |
| Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 recall (Z-1925-2017) | Magellan Diagnostics, Inc. | 2017-05-18 |