The following data is part of a premarket notification filed by Magellan Diagnostics with the FDA for Leadcare Plus Blood Lead Testing System.
| Device ID | K142705 |
| 510k Number | K142705 |
| Device Name: | LeadCare Plus Blood Lead Testing System |
| Classification | Lead, Atomic Absorption |
| Applicant | Magellan Diagnostics 101 Billerica Ave. Bldg #4 North Billerica, MA 01862 |
| Contact | Reba Daoust |
| Correspondent | Reba Daoust Magellan Diagnostics 101 Billerica Ave. Bldg #4 North Billerica, MA 01862 |
| Product Code | DOF |
| CFR Regulation Number | 862.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-22 |
| Decision Date | 2015-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850355006185 | K142705 | 000 |
| 00850355006116 | K142705 | 000 |
| 00850355006062 | K142705 | 000 |
| 00850355006031 | K142705 | 000 |