Submission Details
| 510(k) Number | K123563 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 2012 |
| Decision Date | August 20, 2013 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
Aug 2013
Decision
274d
Days
Class 2
Risk
About This 510(k) Submission
K123563 is an FDA 510(k) clearance for the LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM, a Lead, Atomic Absorption (Class II — Special Controls, product code DOF), submitted by Magellan Diagnostics (North Billerica, US). The FDA issued a Cleared decision on August 20, 2013, 274 days after receiving the submission on November 19, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3550.
Device Classification
| Product Code | DOF — Lead, Atomic Absorption |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3550 |
Manufacturer
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