The following data is part of a premarket notification filed by Esa Biosciences Inc. with the FDA for Leadcare Ii Blood Lead Testing System.
| Device ID | K052549 |
| 510k Number | K052549 |
| Device Name: | LEADCARE II BLOOD LEAD TESTING SYSTEM |
| Classification | Lead, Atomic Absorption |
| Applicant | ESA BIOSCIENCES INC. 22 ALPHA RD. Chelmsford, MA 01824 -4171 |
| Contact | Harold Asp |
| Correspondent | Harold Asp ESA BIOSCIENCES INC. 22 ALPHA RD. Chelmsford, MA 01824 -4171 |
| Product Code | DOF |
| CFR Regulation Number | 862.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-16 |
| Decision Date | 2005-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850355006178 | K052549 | 000 |
| 00850355006123 | K052549 | 000 |
| 00850355006109 | K052549 | 000 |
| 00850355006093 | K052549 | 000 |
| 00850355006086 | K052549 | 000 |
| 00850355006079 | K052549 | 000 |
| 00850355006017 | K052549 | 000 |
| 00850355006000 | K052549 | 000 |