The following data is part of a premarket notification filed by Cambridge Bioscience Corp. with the FDA for Human Lyme Eia For The Detect Of Antibodies.
| Device ID | K890281 |
| 510k Number | K890281 |
| Device Name: | HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | CAMBRIDGE BIOSCIENCE CORP. 365 PLANTATION ST. Worcester, MA 01605 |
| Contact | Jack Cassorla |
| Correspondent | Jack Cassorla CAMBRIDGE BIOSCIENCE CORP. 365 PLANTATION ST. Worcester, MA 01605 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-17 |
| Decision Date | 1989-03-15 |