The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Ultrasensitive Insulin Assay.
| Device ID | K953084 |
| 510k Number | K953084 |
| Device Name: | ACCESS ULTRASENSITIVE INSULIN ASSAY |
| Classification | Radioimmunoassay, Immunoreactive Insulin |
| Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Dennis Griffin |
| Correspondent | Dennis Griffin BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | CFP |
| CFR Regulation Number | 862.1405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-03 |
| Decision Date | 1995-09-25 |