The following data is part of a premarket notification filed by Esa, Inc. with the FDA for Leadcare Blood Lead Testing System.
| Device ID | K971640 |
| 510k Number | K971640 |
| Device Name: | LEADCARE BLOOD LEAD TESTING SYSTEM |
| Classification | Lead, Atomic Absorption |
| Applicant | ESA, INC. 22 ALPHA RD. Chelmsford, MA 01824 -4171 |
| Contact | James Mayol |
| Correspondent | James Mayol ESA, INC. 22 ALPHA RD. Chelmsford, MA 01824 -4171 |
| Product Code | DOF |
| CFR Regulation Number | 862.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-02 |
| Decision Date | 1997-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850355006161 | K971640 | 000 |
| 00850355006154 | K971640 | 000 |
| 00850355006147 | K971640 | 000 |
| 00850355006130 | K971640 | 000 |