The following data is part of a premarket notification filed by Bioarray Solutions Ltd with the FDA for Ena Igg Beadchip Test System, Array Imaging System, Models 800-00025, Ais 400.
| Device ID | K043067 |
| 510k Number | K043067 |
| Device Name: | ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | BIOARRAY SOLUTIONS LTD 35 TECHNOLOGY DRIVE SUITE 100 Warren, NJ 07059 |
| Contact | Kevin Wyckoff |
| Correspondent | Kevin Wyckoff BIOARRAY SOLUTIONS LTD 35 TECHNOLOGY DRIVE SUITE 100 Warren, NJ 07059 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-08 |
| Decision Date | 2005-05-31 |
| Summary: | summary |