LEADCARE BLOOD LEAD TESTING SYSTEM
FDA 510(k) clearance K971640 · decided 1997-09-09
Clearance details
- K-number
- K971640
- Device name
- LEADCARE BLOOD LEAD TESTING SYSTEM
- Applicant
- Esa, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-02
- Decision date
- 1997-09-09
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- DOF
- Device class
- 2
- Regulation number
- 862.3550
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Chelmsford, 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 (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM (K123563) | Magellan Diagnostics | 2013-08-20 |
| LEADCARE II BLOOD LEAD TESTING SYSTEM (K052549) | Esa Biosciences, Inc. | 2005-10-06 |
| 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 |
|---|---|---|
| Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood recall (Z-2225-2017) | Magellan Diagnostics, Inc. | 2017-06-05 |
| LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233 recall (Z-0914-05) | Esa Biosciences, Inc. | 2005-06-21 |