The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Low Level Ige Controls.
| Device ID | K953883 |
| 510k Number | K953883 |
| Device Name: | ACCESS LOW LEVEL IGE CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-18 |
| Decision Date | 1995-11-14 |