The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Specific Ige Assay.
| Device ID | K935876 |
| 510k Number | K935876 |
| Device Name: | ACCESS SPECIFIC IGE ASSAY |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Joan Christenson |
| Correspondent | Joan Christenson BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-09 |
| Decision Date | 1994-03-11 |