The following data is part of a premarket notification filed by Cambridge Biotech Corp. with the FDA for Cambridge Biotech Human Lyme Igm Western Blot (90112).
| Device ID | K971170 |
| 510k Number | K971170 |
| Device Name: | CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112) |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | CAMBRIDGE BIOTECH CORP. 1500 EAST GUDE DR. Rockville, MD 20850 -5307 |
| Contact | Rebecca Leaper |
| Correspondent | Rebecca Leaper CAMBRIDGE BIOTECH CORP. 1500 EAST GUDE DR. Rockville, MD 20850 -5307 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-28 |
| Decision Date | 1998-02-17 |
| Summary: | summary |