The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Ultimate Direct & Total Bilirubin Contro.
| Device ID | K802068 |
| 510k Number | K802068 |
| Device Name: | ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BECKMAN INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-27 |
| Decision Date | 1980-10-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590228705 | K802068 | 000 |
| 15099590223038 | K802068 | 000 |
| 15099590223021 | K802068 | 000 |
| 15099590223014 | K802068 | 000 |