The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Bartels Lyme Disease Igm Eia.
| Device ID | K922578 |
| 510k Number | K922578 |
| Device Name: | BARTELS LYME DISEASE IGM EIA |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | BAXTER DIAGNOSTICS, INC. BARTELS DIAGNOSTICS DIVISION P.O. BOX 3093 Bellevue, WA 98009 |
| Contact | Mallinak |
| Correspondent | Mallinak BAXTER DIAGNOSTICS, INC. BARTELS DIAGNOSTICS DIVISION P.O. BOX 3093 Bellevue, WA 98009 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-27 |
| Decision Date | 1992-09-02 |