The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Total Bilirubin Triggered (tb-t) Kit.
| Device ID | K902801 |
| 510k Number | K902801 |
| Device Name: | BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | William T Ryan |
| Correspondent | William T Ryan BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-27 |
| Decision Date | 1990-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590625597 | K902801 | 000 |
| 15099590233075 | K902801 | 000 |