The following data is part of a premarket notification filed by Magellan Diagnostics with the FDA for Leadcare (r) Ultra (tm) Blood Lead Testing System.
| Device ID | K123563 |
| 510k Number | K123563 |
| Device Name: | LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM |
| Classification | Lead, Atomic Absorption |
| Applicant | MAGELLAN DIAGNOSTICS 101 BILLERICA AVE. BLDG #4 North Billerica, MA 01862 -1271 |
| Contact | Stuart Naylor |
| Correspondent | Stuart Naylor MAGELLAN DIAGNOSTICS 101 BILLERICA AVE. BLDG #4 North Billerica, MA 01862 -1271 |
| Product Code | DOF |
| CFR Regulation Number | 862.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-19 |
| Decision Date | 2013-08-20 |
| Summary: | summary |